Therapist's Manual

I. INTRODUCTION

Background

Manual-guided psychosocial therapy was not a component of the European multicenter acamprosate studies. All studies were designed to comply with naturalistic conditions, allowing factors outside of treatment to influence the course of treatment. Patients participating in these trials received the routine supportive care or psychotherapy that was typical of each clinical setting and, in general, treatment contact was relatively infrequent.

A pooled analysis of data from 11 placebo-controlled European multicenter trials of acamprosate found no significant interaction with other forms of treatment, e.g., psychosocial therapy (Mann et al., 1996). In a definitive review of controlled studies, Bien, Miller and Tonigan (1993) concluded that brief counseling may trigger significant behavioral change in a broad range of alcohol-abusing individuals and that there are few, or no, overall differences in effectiveness between more versus less intensive and expensive specialist treatments for alcoholism.

Rationale

There is an ethical obligation to provide treatment to subjects who request services, and are identified as being at risk for alcohol dependence. However, the potential number of treatment-seeking alcoholics surpasses the capacity of available specialists. Therefore, a standardized manual of brief intervention was developed for the U.S. acamprosate study (ACAMP/US/96.1), in order to facilitate comparison with European acamprosate multicenter trials, as well as to provide an effective form of psychosocial intervention that could be easily implemented using the resources standard to most clinical settings. These standard components include ongoing monitoring of medication compliance, feedback to the patient on biological and psychological assessments relevant to drinking, educational handouts, between-session telephone contacts, and letters following missed appointments or telephone calls.

Treatment Overview

The GOAL of the therapist's intervention for this study is to promote abstinence in persons with alcohol dependence by facilitating compliance with medication and by applying motivational enhancement and psychoeducational methods [1]The Physicians' Guide to Helping Patients with Alcohol Problems ) format, that included moderate drinking as a treatment goal, has been modified for the purposes of this study to focus on ABSTINENCE as a treatment goal, given that all acamprosate subjects will be alcohol-dependent.

Therapist's Training

The study therapist shall be a person with at least a bachelor's degree in a relevant field, as well as two years of related experience, and may include registered nurses (R.N.s), Nurse Practitioners, Physician's Assistants, graduate psychology students, social workers, physicians, psychologists, psychiatrists, etc.

Reference Handbooks and Their Caveats

NIAAA's Motivational Enhancement Therapy Manual (MET), developed for Project MATCH, may be used as a reference handbook for the purposes of this study. However, not all of the MATCH instruments are used in ACAMP/US/96.1, nor are "significant others" involved in the treatment as they are in the MET manual (even though each patient in this study is required to have a collateral informant who may, in fact, be a "significant other") .

Additionally, patients are not to be told that slips are a natural part of recovery in advance of any drinking that may occur during the study. Rather, the focus is on achieving and maintaining abstinence .

Patients are given information about local self-help groups at the initiation of treatment. NIAAA's Twelve Step Facilitation Therapy Manual , also developed for Project MATCH, may be helpful for learning key phrases and concepts of Alcoholics Anonymous (AA). However, confrontational, directive, skills building, or family therapy strategies are not appropriate for the purposes of the current study.

II. SUMMARY OF BRIEF INTERVENTION PROCEDURES

The first two sessions with the therapist at the time of the initial study visits (Screening Visit [Visit -1] and Baseline/Randomization Visit [Visit 0]) use the study assessment procedures from the Case Report Form (CRF) to ASK about alcohol use, ASSESS for alcohol-related problems, and ADVISE appropriate action. At these visits, patients will be providing information about their personal and family history of alcohol use, their employment and domestic/social circumstances, and will also identify a collateral informant, who will be independently contacted during the study for information on the patient's drinking behavior. At the initial sessions with the therapist, handout materials will be given to the patient ( see also Section V., Screening Visit and Section VI., Baseline/Randomization Visit ), a Treatment Progress Summary Sheet will be started and the patient will be aided in establishing therapeutic goals.

Thereafter, sessions with the therapist will be oriented toward using information on interim drinking behavior and abstinence (both patient reported and that reported by the collateral informant) as it relates to medication compliance, therapeutic goals and changes in biological and psychosocial assessments that are part of the protocol. Patients will be shown their progress (hopefully!) on their individualized Treatment Progress Summary Sheet.

In general, each session should be ended by summarizing what has transpired in the session, including:

  • review of medication compliance ,
  • any positive changes from pretreatment ,
  • any concerns that the patient has,
  • evidence of their motivation , and
  • the goals identified for the next treatment period.

A key element of both the study efficacy outcome endpoints as well as the brief intervention, is the drinking Timeline Follow Back (TLFB) interview. Ideally, this should be done by the therapist in conjunction with the brief intervention session.  The initial TLFB (at Visit 0) will explore drinking behavior during the three months prior to study enrollment. Thereafter, the TLFB (performed at each visit) involves the interval between study visits.

Information on drinking may have been obtained during interim scheduled telephone contacts with the patient. Accordingly, the Telephone Log Book should be reviewed to facilitate the accuracy of the TLFB data.

To help them recall any drinking activity, patients will be given a Drinking Diary calendar at each visit (including Visit -1), along with their study medication packet(s) and will be asked to record the number of standard drinks per day, if any, on a daily basis. They will be asked to return this calendar at each visit for use during the TLFB. Prior to review of interim drinking behavior, the returned medication packets will be examined by the interviewer and any tablets not taken will be noted on the TLFB calendar ( see section on Medication Compliance, below ) [2] . An important component of the intervention is to reinforce returned pill counts that show compliance with the prescribed dose and to relate any missed doses to any episodes of drinking .

In the sections that follow, further details on the brief intervention for this study--including suggested interview dialogue--are provided. In addition, a section devoted to Special Topics should help you "trouble shoot" many situations that may arise.

III. THERAPEUTIC TECHNIQUES

General

Begin by examining your own attitudes toward patients with alcohol problems.

  • Respect patients' perceptions about their drinking while helping them change their beliefs.
  • Acknowledge that many patients see both positive and negative aspects of their drinking.
  • Recognize that patient motivation is key to changing drinking behavior.

Motivation for change occurs when people perceive a discrepancy between where they are and where they want to be. The approach which will be used in this study seeks to enhance and focus the patient's attention on such discrepancies with regard to their drinking behavior. In certain cases it may be necessary first to develop such discrepancy by raising patient's awareness of the personal consequences of their drinking. As a result, the individual may be more willing to enter into a frank discussion of change options.

Decisions to change behavior are not always easy to make and often involve fluctuating motivation and feelings of ambivalence. Those who are not quite ready to change may vacillate over modifying their drinking habits before committing to a course of action. Ambivalence on the part of the patient in study participation and the goal of abstinence is viewed as normal , not pathological, and is explored openly. Your communication strategies should take the patient's level of motivation into account.

New ways for the patient to think about problems are to be invited but not imposed . Solutions are usually evoked from the patient rather than provided by the therapist .

In this study, the following communication strategies should be used, particularly if, during the course of the study, patients show signs of at-risk or problem drinking:

  • Provide personalized feedback about the patient's drinking patterns and related health risks.
  • Assume a nonjudgmental stance , summarizing and clarifying the information provided.
  • Use an empathic, nonconfrontational style .
  • Emphasize patient responsibility for changing.
  • Offer patients a number of strategies to effect change.
  • Assure patients that they are capable of developing the skills they need to effect change.

Helpful Hints for Communicating with Patients

Communication techniques that can be effective in increasing patient motivation include the following:

  • Reflective listening:

Restate in your own words what you hear your patients saying. This can serve as a means of acknowledging your patients' feelings ("You seem to be saying that....") or as a means of clarifying their statements ("....is this your understanding as well?").

  • Affirmation:

Include statements of appreciation and understanding that convey confidence and mutual respect, such as: "I appreciate your honesty. You have a good understanding of situations that cause problems for you."

  • Open-ended questions:

Use open-ended questions to better understand your patients' perspectives on the problem, such as: "What do you think about your drinking?"

  • Empathy:

Avoid confrontation and do not use labels such as "alcoholic" or "problem drinker"; instead, talk about specific consequences of drinking behavior.

Conversely, certain kinds of reactions on the part of the therapist are likely to exacerbate resistance , back the patient further into a corner , and elicit antimotivational statements from the patient. These therapist responses include:

  • Arguing, disagreeing, challenging.
  • Judging, criticizing, blaming.
  • Warning of negative consequences.
  • Seeking to persuade with logic or evidence.
  • Interpreting or analyzing the "reasons" for resistance.
  • Confronting with authority.
  • Using sarcasm or incredulity.

Remember, your attitudes and style of communicating are important factors in motivating patients to change their drinking behavior!

IV. MEDICATION COMPLIANCE ( see also Special Topics, Section IX A., for additional discussion on Medication Issues )

In general, accurate assessment of medication efficacy and tolerability can only occur if medication is taken consistently and as prescribed. In clinical trials, determining and ensuring adequate compliance is critical for evaluation of the benefit/risk ratio of any new medication.

In the European experience, acamprosate was associated with significantly higher rates of abstinence and treatment retention compared to placebo in 10 of the 11 multicenter trials. Therefore, in the current U.S. study, facilitating medication compliance (and verification of such compliance) is a key component of each post-screening study visit. Medication compliance procedures require that you (or other study personnel):

  • Carefully explain to the patient the importance of taking their study medication as directed.
  • Make sure that patient understands he/she is to bring back all previously dispensed medication at each post-screening visit.
  • Initially, carefully explain to the patient (and confirm his or her comprehension) how to complete the Drinking Diary calendar between visits, using standard drink icons.
  • Explain how the Drinking Diary information will be used during post-Screening visits (in the drinking Timeline Follow Back interview) and the importance of bringing the completed Drinking Diary calendar back at each visit.
  • At the Baseline/Randomization visit, review the Patient Information Sheet on Acamprosate with the patient, in order to allay any concerns and identify strategies to optimize medication compliance.
  • Collect and review returned blister packs of medication at each post-screening visit.
  • Enter the number of pills not taken (missed) on every relevant day of the TLFB calendar.
  • Reinforce returned pill counts that show compliance with prescribed dose. E.g., "I am encouraged that you took all your medication as prescribed. This is an indication that you are working constructively toward your treatment goal."
  • Relate any missed doses to any episodes of drinking. E.g., " I notice that you forgot to take your medication on the day you had a slip."
  • Use strategies of information-sharing and problem-solving for non-compliance ( see also Special Topics, Section IX A., for additional discussion on Medication Issues ) .

V. SCREENING VISIT (VISIT -1)

In this initial session, the first three steps of the brief intervention will be introduced-- ASK, ASSESS and ADVISE . You will need information from selected Screening Visit case report form (CRF) pages to aid you in the intervention process.

Beginning the First Brief Intervention Session

You may wish to begin the session and introduce what will happen during the patient's study participation (particularly as it relates to the therapy), as follows [3] :

(Suggested dialogue)

I understand that you are interested in participating in the acamprosate study for patients with alcohol dependence.

Before we begin, let me just explain a little about how we will be working together. You have already spent time completing a number of the tests that we need, and we appreciate the effort you put into that process. We will make good use of the information from those tests today, including your blood and urine test results.

This is the first session that we will be spending together, during which we will take a close look together at your drinking situation. I hope that you will find this session interesting and helpful.

I should explain right up front that I am not going to be changing you. I hope that I can help you think about your present situation and consider what, if anything, you might want to do, but if there is any changing, you will be the one who does it . Nobody can tell you what to do; nobody can make you change. I'll be giving you a lot of information about yourself and maybe some advice, but what you do with all of that is completely up to you. I couldn't change you if I wanted to! The only person who can decide whether and how you change is you.

In this study we will use a brief drinking-focused counseling approach that gives you information about the effects of alcohol on your medical and psychosocial functioning. It also helps you to identify your most effective ways to handle urges to drink, and provides feedback on how you are meeting your treatment goals--treatment goals that we will work on together.

This type of brief counseling has been found effective in reducing alcohol use and alcohol-related problems for many people. The medication we are studying--acamprosate--has also been found helpful for many persons with alcohol dependence who are seeking to maintain abstinence. We will be monitoring your recovery in relation to your taking this medication.

Your brief counseling program and medication may be useful resources in helping you to take responsibility for your recovery from alcohol dependence.

How does that sound to you?"

Many patients will find this a very comfortable and compatible approach. Some, in fact, will express relief, having feared that they would be coerced into discontinuing drinking or be chastised for drinking.

Other patients, however, may be uneasy with this approach and may need additional explanation and/or reassurance. Here are several lines of follow-up discussion in such cases:

(Suggested dialogue)

  • Even with very extensive kinds of treatment, it is still the person who, in the end, decides what happens. You will determine what happens with your drinking.
  • Longer and shorter treatment programs don't see different results. People in longer or more intensive programs do not do any better, overall, than those getting good consultation like this. Again, no one can "do it for you." In fact, many people change their drinking or quit smoking without any formal treatment at all!
  • You are not alone. We will be keeping in touch with you to see how you are doing.
  • I understand your worries, and it is perfectly understandable that you would be unsure at this point. Let us just get started, and we will see where we are after we have had a chance to work together!

ASK about Alcohol Use

At this point, you should be ready to move on to the first step of the brief intervention: namely, ASK about alcohol use, using specific, personalized information on drinking, obtained from the patient during the Screening Visit [4]

(Suggested dialogue for ASK)

  • Today I would like to review your alcohol use and symptoms of alcohol dependence with you.
  • In looking over your information, I see you reported you were _____years old (CRF Pg. 11, Q. 2) when you first began having problems with drinking.
  • You have been drinking heavily for _____years (CRF Pg. 11, Q.3) .
  • How do you feel about your drinking?
  • What do you like about your drinking?
  • What don't you like as much about your drinking?
  • What personal goals are important to you? ( Examples might include: family, physical fitness, career advancement, etc. )
  • Does drinking interfere with meeting any of these goals?

Summarizethe pros-- then the cons-- in the patient's responses to these questions, using "you" language, in order to highlight ambivalence.

ASSESS for Alcohol-Related Problems

Next, you ASSESS for alcohol-related problems , as follows :

(Suggested dialogue for ASSESS)

  • I notice that you can have _____ drinks in one sitting before feeling intoxicated (CRF Pg. 11, Q. 5) .

If >3 for a male patient or >2 for a female patient, state:

This suggests that you may have become tolerant to the effects of alcohol. You may need to drink more now than when you first started drinking in order to feel the same effect of drinking.

** Some people are proud of this tolerance - the ability "to hold your liquor" - and think it means they are not being harmed by alcohol. Actually, the opposite is true. Tolerance for alcohol may be a serious risk factor for alcohol problems. The person with a high tolerance for alcohol reaches high blood alcohol levels, which can damage the brain and other organs of the body but has no built-in warning that it is happening.

Tolerance is not a protection against being harmed by drinking; to the contrary, it makes damage more likely because tolerance has more to do with actually being at a high blood alcohol level and not feeling it. This is a symptom of what we call alcohol dependence .

If <4 for a male patient or <3 for a female patient, ask:

Do you need to drink more now than when you first started drinking in order to feel the same effects of drinking?

  • If yes,state: This suggests that you may have become tolerant to the effects of alcohol ( at this point, continue with suggested dialogue above, marked with a double asterisk** ). This is a symptom of what we call alcohol dependence.
  • If no, proceed with remaining ASSESS dialogue .

(Continuing now with suggested dialogue for ASSESS)

An individual is at increased risk for alcohol-related problems if one or both parents had alcohol problems. I see that your father (did/did not) have problems because of his own drinking, and that your mother (did/did not) have problems because of her own drinking ( review Family Alcohol History with patient, CRF Pg. 11).

Use of other drugs--particularly "street drugs" or " mood-altering" drugs--may also increase alcohol-related problems (review Other Substance Use Problems with patient, CRF Pg. 11-13).  It is important that you not use any of this type of drug during the study (by the way, that also includes smoking marijuana). Certainly, if you are on medications which are prescribed by a physician for other health conditions, most likely you will be able to continue taking these. The important thing is that you inform us as to what you are taking or even if the dose or number of tablets of any medication you are on is changed .

Problems we have noted that relate to your drinking include _____________ ( review all positive symptoms from DSM IV Checklist, CRF Pg. 18). This pattern of alcohol-related problems indicate that you have become dependent on alcohol .

ADVISE to Abstain from Alcohol Consumption

Next, you ADVISE to abstain from alcohol consumption , as follows:

(Suggested dialogue for ADVISE)

I strongly believe that you should stop drinking altogether!

You have:

  • a history of severe alcohol problems and dependence.
  • unsuccessful prior attempts to cut down or quit drinking.

Successful abstinence is a safe choice. If you don't drink, you can be sure that you won't have problems because of your drinking.

There are good reasons to at least try a period of abstinence to find out what it's like to live without alcohol and to learn how dependent you have become on alcohol ( other reasons you might suggest to the patient include: to experience a change, build some confidence, to please your spouse, etc. ). Your ability to think is likely to improve. Heavy drinking over a long time dulls the mental abilities important for learning new skills. These abilities, however, sharpen again , after 2-3 weeks of abstinence. This will, in turn, make it easier for you to accomplish whatever goals you set .

One thing is certain, no one can guarantee a safe level of drinking that will cause no harm.

If you continue to drink, your dependence will get worse and it will be even harder to stop. Not everyone finds it easy to change habits, such as eating, smoking, or drinking. (Following this discussion, ask the patient)

  • How do you feel about what I have said?
  • Is your drinking of concern to you?
  • Is your drinking of concern to anyone else?

   If drinking is of concern to patient:

  • EXPRESS concerns, saying:   I do share your concern about your drinking and I am eager to work with you on this problem.
  • EXPLORE concerns, asking:   What makes your drinking of concern to you?  Give me some examples of the concerns you have about your drinking?  In what way has drinking caused you problems?
  • ENCOURAGE/ASSESS MOTIVATION, by asking:  Would you be willing to work on a plan to stop drinking?
  • If drinking is not of concern to patient:
  • EXPRESS concerns, saying:   Although it does not feel like a problem to you, I am concerned about your drinking. Would you like to change this?
  • EXPLORE potential concerns, asking:   Has your drinking ever caused you a problem?  How?  Would you like to change this?  Could you think about how your drinking might cause you a problem in the future?
  • ENCOURAGE/ASSESS MOTIVATION, by asking:  Would you be willing to read some materials and think about your drinking?  What changes in your drinking would you consider?

Patient Brochure

At this point, the patient should be given the Patient Brochure to review with the therapist and to take home. This brochure Includes:

  • information about harmful effects of drinking;
  • tips on how to quit drinking;
  • space to itemize personal reasons for quitting, define treatment goals and document successful strategies for coping with urges to drink.
  • space to fill in telephone numbers and meeting times and places of AA groups, near home and work or school.

12-Step Groups

12-step groups such as Alcoholics Anonymous (AA)should be introduced as a support that many persons with alcohol dependence find helpful when they are seeking to establish an alcohol-free lifestyle. Mention that attendance at AA is not required for participation in the study's treatment program, but that patients should feel free to attend AA if they find it helpful, and that you will keep track of their attendance at AA meetings throughout the study. As noted above, patients should be provided with local AA telephone numbers and locations.

Givethe patient the AA Brochure entitled: "the AA member-Medications & other Drugs", saying: ęf you think you are going to attend AA, you might be interested in this brochure."

Visit Conclusion

Concludethe first brief intervention by summarizing the patient's concerns, motivation and short term goals , as follows:

(Suggested dialogue)

Is there more information I can provide you? (Patient responds)

What I heard today was _________________________ (summarize patient's concerns, motivation and short term goals).

Is there anything else I can do to help?

Make arrangements for the next visit, as follows:

(Suggested dialogue)

I would like to see you again in about 2-4 days, to talk some more and to review your lab work. When would be a good time for you? (Patient responds)

VI. BASELINE/RANDOMIZATION VISIT (VISIT 0)

Ineligible to Continue Study Participation and Randomization

Based on the totality of available information (history, physical examination, laboratory results, fulfillment of inclusion/exclusion criteria, evidence of ability to comply with study requirements, etc.), a decision will have been made as to whether or not the patient is eligible for randomization to the Acamprosate/Placebo Treatment Phase of the study.

In the event the patient is not admitted to the study, the following intervention should occur:

  • briefly review any significant laboratory findings;
  • offer an appropriate treatment referral ( you may call the referral for the patient or offer the referral information to the patient in writing);
  • reinforce the patient's motivation to change.

Eligible to Continue Study Participation and Randomization

For patients who are eligible for randomization and continued study participation, the second brief intervention session will take place. For this visit, information from both the Screening and Baseline CRF pages will be needed.

Overview of Baseline/Randomization Intervention Session

At this session, additional information acquired from or about the patient will be reviewed, particularly with regard to any laboratory parameters that might reflect effects of alcohol. Thus, the process of ASSESS and ADVISE continues. The first drinking Timeline Follow Back (3 month retrospective) will be performed, selected numerical/statistical information on drinking will be reviewed with and given to the patient, a Treatment Progress Summary Sheet will be created (to begin the MONITORING of progress), and the patient will be assisted in establishing treatment goals, by means of a Treatment Goals Worksheet, a copy of which will be given to the patient. A Medication Information Sheet about Acamprosate will be given to the patient, to be reviewed with the therapist and then taken home.

Conducting the Second Brief Intervention Session

During this session, the following actions need to be taken:

  • Complete the drinking Timeline Follow Back (TLFB) interview, covering the preceding three month time period [5] .
  • Reinforce any decrease in drinkingsince the last visit, by saying, e.g.:

"Congratulations on taking positive action" (specify nature of decrease in drinking) .

  • Resolve any discrepanciesbetween the TLFB and the collateral informant's report ( CRF Pg. 30-33, DrInC-2R-SO ) .
  • Reinforcereturned pill counts that show compliance with prescribed dose , by saying, e.g.:

"I am encouraged that you took all your medication as prescribed. This is an indication that you are working constructively toward your treatment goal."

  • Relateany missed doses to any episodes of drinking , by saying, e.g.:

"I notice that you forgot to take your medication on the day you had a slip. The medication can only help you to maintain abstinence if you take it consistently, like an antibiotic. It does not work like an aspirin, to be taken only on those occasions when you feel you need it."

Treatment Progress Summary Sheet and Drinking Norms

  • Begin entering relevant data from Visit -1 and Visit 0 onto the patient's Treatment Progress Summary Sheet (TPS Sheet) [6] , as follows:
  1. In reviewing the TLFB of the three months prior to seeking treatment, select the week with the greatest number of total drinks consumed and enter this number on the patient's Treatment Progress Summary Sheet for Visit 0.
  2. Calculate [7] the weekly cost of at home and bar drinking and the average weekly number of calories associated with drinking and enter these values in the appropriate Visit 0 box of the TPS Sheet. Discuss these results with the patient, as follows:

"These are costs estimated for your pretreatment drinking - if you drank entirely at home, you are spending approximately ($____per week) on drinks; if you drank entirely in a bar, you are spending approximately ($____per week) on drinks. You also consumed about (XXXX calories per week) associated with this amount of drinking."

  1. Based on the above-tallied number of weekly drinks, show the patient where their drinking behavior fits on the U.S. Drinking Comparison pie chart and on the table of Alcohol Consumption Norms for U.S. Adults , saying, e.g.:

"This is where your drinking fits in, compared to U.S. patterns of alcohol use for men and women."

  1. Based on the above-tallied number of weekly drinks, review with the patient each of the relevant potential health risks of drinking, based on the Individualized Drinking Health-Risk Consequence graph , saying, e.g.:

"These are some of the health risks associated with the amount of alcohol you were drinking before coming in to treatment."

The patient is then given the pie chart, graph and table to take home with them.

  • Share results of Visit -1 laboratory evaluations with the patient, with particular emphasis on the results of liver function evaluation, and enter the values in the respective Visit -1 boxes of the TPS Sheet , saying to the patient, e.g.:

"Your last evaluation included analyses of a blood sample. These particular blood tests--related to how the liver is working--were chosen because they have been shown in previous research to be negatively affected by heavy drinking.

As you probably know, your liver is extremely important to your health. It is involved in producing energy, and it filters and neutralizes impurities and poisons in your bloodstream.

Alcohol damages the liver, and after a long period of heavy drinking, parts of the liver begin to die . This is the process called cirrhosis --a type of scarring of the liver--but physical changes in the liver can be caused by drinking long before cirrhosis appears. As the liver becomes damaged, it begins to leak enzymes into the blood and is less efficient in doing its work. This can be reflected in abnormally high values on these tests and this is what we look for in patients who we know are drinking heavily.

  1. If the patient's liver function tests are normal , you should say something like:

Normal results on these tests do not guarantee that you are in good health: specifically, that your liver is functioning completely normally.

  1. If the patient's liver function tests are abnormal , you should say something like:

An abnormal score on one or more of these tests probably reflects unhealthy changes in your body resulting from excessive use of alcohol and/or other drugs.

Research indicates that modestly abnormal scores on the blood tests reported here will often show improvement and a return to the normal range when harmful drinking and other drug use patterns are changed . The longer one continues drinking, however, the more difficult it is to reverse the physical damage.

Creation of Treatment Goals Worksheet

Toward the end of this session, the Treatment Goals Worksheet (TGW) [8] will be created, in order to help specify the patient's action plan. It allows the patient to:

  • decide on the changes he/she want to make;
  • identify why these changes are important ;
  • enumerate the steps they plan to take to achieve change ;
  • identify how others can help in this process;
  • project how he/she will know that the plan is working ;
  • recognize potential interference with success.

A sample of the TGW, along with suggested approaches to information-gathering for each point, can be found at the end of this section.

The information needed to develop the TGW should emerge through the motivational dialogue with the patient and through review of the patient's notes on urges to drink and coping strategies .

To ensure that you cover all of the above aspects of the patient's plan, use the TGW as a guide while you review with the patient each point. Make relevant queries, whenever needed, and complete the form. You may also use the TGW for taking notes or making comments as the patient's plan emerges. Once the form has been satisfactorily completed, the original should be given to the patient to take home, with the second part of the NCR form retained in the appropriate section of the Therapist's Manual.

Dealing with the Patient Who Is Reluctant to Commit to Change:

Some patients are unwilling to commit themselves to a change program. When patients remain ambivalent or hesitant about a written or verbal commitment to commit to abstinence , you may ask them to defer the decision until later . In that case, a specific time should be agreed upon to reevaluate and resolve the decision. Such flexibility provides patients the opportunity to explore more fully the potential consequences of change and prepare themselves to deal with the consequences. Otherwise, patients may feel coerced into making a commitment to abstinence before they are ready to take action .

Additionally, in such cases, patients may withdraw prematurely from treatment , rather than "lose face" over the failure to follow through on a commitment. It can be better, then, to say something like this:

"It sounds like you are really not quite ready to make a decision about abstinence yet. That is perfectly understandable. This is a very tough choice for you. It might be better not to rush things here, not to try to make a decision right now.

Why don't you think about it between now and our next visit. Consider the benefits of making a change compared to staying the same . We can explore this further next time, and sooner or later I am sure it will become clear to you what you want to do. OK?"

It can be helpful in this way to express explicit understanding and acceptance of patients' ambivalence as well as confidence in their ability to resolve the dilemma .

If the Feedback Process Cannot Be Completed in One Session

You might not complete this feedback process in one session. If not, explain that you will continue the feedback in your next session, and take back the patient's TGW for use in your next session, indicating that you will give it back to the patient, to keep, after you have completed reviewing the feedback at the next visit .

If you do complete the feedback process, ask for the patient's overall response. One possibly query would be:

"I have given you quite a bit of information here, and at this point, I wonder what you make of all this and what you are thinking?

Both the feedback and this query will often elicit self-motivational statements that can be reflected and used as a bridge to the next phase of treatment.

Reaffirm that consistently taking the study medication may help in meeting the patient's treatment goal of abstinence.


Medication Information Sheet

Dispense and review the Medication Information Sheet on Acamprosate with the patient, making sure to cover the following points ( see Section IX A, Special Topics, Medication Issues, for additional details) :

  • how acamprosate works ;
  • dosing ;
  • side effects ;
  • concerns .

Visit Conclusion

At the conclusion of the session, ask the patient: "Is there more information I can provide you?

Finally, make arrangements for the next visit .


Sample of Treatment Goals Worksheet(with suggested approaches in italics).

1. The changes I want to make are:

 

In what ways or areas does the patient want to make a change?  They should be specific.

Inclusion of positive goals is important, (such as wanting to begin, improve, do more of something).

Avoid establishing only goals that could be accomplished by "general anesthesia" (e.g., to

stop or decrease certain behaviors).

 

2. The most important reasons why I want to make these changes are:

What are the most likely consequences of action versus inaction ?

Which motivations for change seem most compelling to the patient?

 

3. The steps I plan to take in changing are:

 

How does the patient plan to achieve the goals?  How could the desired change be accomplished?

Within the general plan and strategies described, what are some specific, concrete first steps

that the patient can take? 

When, where and how will these steps be taken?

   

4. The ways other people can help me are:

 

In what ways could other people (including the significant other) help the patient in taking these

steps toward change? 

How will the patient arrange for such support?

   

a. Person(s)

 
   

b. Possible ways to help:

 
   

5. I will know that my plan is working if:

 

What does the patient hope will happen, as a result of this plan?

What benefits could be expected from this change?

   

6. Some things that could interfere with my plan are:

Help the patient to anticipate situations or changes that could undermine the plan.

What could go wrong?  How can the patient stick with the plan despite these

problems or setbacks?

 


VII. ACAMPROSATE/PLACEBO TREATMENT PHASE VISITS (VISITS 1-8) AND FIRST FOLLOW-UP PHASE VISIT (VISIT 9)

At each of these visits, the following general procedures should be carried out:

  • Begin each session with a discussion of what has transpired since the last session and a general review of what has been accomplished in previous sessions.
  • Review the returned medication packages for compliance assessment and perform the interim drinking Timeline Follow Back , based on the patient's Drinking Diary calendar, whenever possible.
  • Address any issues related to medication compliance or discrepancies between TLFB and collateral informant reports .
  • Remind your patients that drinking patterns often are changed through a series of small steps over time. Offer your ongoing support and monitor their progress during regularly scheduled study visits.
  • Review your patients' drinking goals and discuss progress since the last visit. Ask, for example:
  1. "How has it gone since our last visit?
  2. How well were youable to meet your drinking goal?
  3. What went well?  Whatwas difficult?"
  4. What are your thoughts about your drinking now?"
  • Reinforce positive change and assess continued motivation by saying, for example:
  1. "Congratulations on taking positive action ( note specific actions ).
  2. Change often occurs in small steps.
  3. Are you ready to make any other changes?  What would they be?"
  • If the patient is having problems meeting targets of Treatment Goals Worksheet , comments might include:
  1. " I am encouraged that you came back to talk about the problems you are having in meeting your goal. Change often occurs through trial and error. How are you feeling about your efforts?" .

Such a patient may be helped with problem solving by asking, for example:

  1. "What do you think is getting in the way of meeting your goal?  Particular social situations?  Life stresses?"
  2. "Let us review the strategies you used.  Which strategies worked best for you?  What are some different strategies that may be useful?"
  • MONITOR changes from Baseline/Randomization (Visit 0) in the average number of drinks per week, craving scale results, liver function test results and other biological or psychosocial assessments.
  • Complete the Treatment Progress Summary Sheet , using information from the patient and from the CRF.
  • End each session with a summary of where the patient is at present , eliciting the patient's perceptions of what steps should be taken next . ( Remember, the prior Treatment Goals Worksheet can be reviewed and revised or rewritten, as necessary ).
  • Schedule the patient's next session .

Specific Recommendations for Visit 7

At Visit 7, remind the patient that this will be their last month on study medication, but that their progress will continue to be monitored by the therapist for an additional two months .

Specific Recommendations for Visit 8

At Visit 8 , reassure the patient that, although study medication is being discontinued, their progress will continue to be monitored by the therapist for two additional months.

Specific Recommendations for Visit 9

At Visit 9, assess the patient's clinical status off study drug, reminding the patient that there still remain 7 weeks of follow-up.

Reviewthe Treatment Progress Worksheet , pointing out the beneficial effects of having participated in the study.

Emphasize that although there will be only one additional session as part of the study, the patient has already been off study drug for one week and reassure the patient that he/she is capable of maintaining the gains:

  • Point out that the remaining weeks in the study will provide him/her with time to crystallize those life style changes made while on study medication, during an additional drug-free period , with monitoring and support from the therapist and other site personnel for an additional 7 week period.
  • Finish the session by telling them that they are taking the final step toward extending these lifestyle changes to their life outside of and beyond treatment.

If drinking has occurredsince discontinuation of study medication, follow procedures for handling slips and relapses ( see Section IX F, Special Topics, Strategies for Handling a Drinking "Slip"...) .


VIII. FINAL VISIT DURING FOLLOW-UP PHASE (VISIT 10)

Formal termination should be acknowledged and discussed at the end of the tenth session (Visit 10). This is generally accomplished by a final recapitulation of the patient's situation and progress through the counseling sessions .  Your final summary should include these elements:

  • Review the most important factors motivating the patient for change , and reconfirm these self-motivational themes .
  • Summarize the commitments and changes that have been made thus far.
  • Affirm and reinforce the patient for commitments and changes that have been made.
  • Explore additional areas for change that the patient wants to accomplish in the future.
  • Elicit self-motivational statements for the maintenance of change and for further changes.
  • Support patient self-efficacy , emphasizing the patient's ability to change.
  • Deal with any special problems that are evident (see section on Special Topics) .
  • Inform the patient that appropriate referrals for additional treatment can be provided, if needed.

IX. SPECIAL TOPICS

A. MEDICATION ISSUES

1. Patient Has Concerns about Taking Medication

If the patient has concerns about taking medication, reassurance on the following points can be given:

  • Acamprosate has already been approved by government authorities (comparable to the U.S. Food and Drug Administration [FDA]) for the treatment of alcohol dependence in more than 10 European countries and has been available, by prescription, in France for almost ten years.
  • Over 3,000 patients have been treated with acamprosate in controlled clinical studies, similar to the current study and at the same dose as is being used by most patients in this study, with NO serious treatment-related adverse effects . Furthermore, more than one million people have received acamprosate since it has been on the market in Europe, with no serious safety concerns reported.
  • Even though some patients in this study are on a higher dose of acamprosate than currently used in Europe, the side effect profile of the drug is very good and there have been patients and volunteers treated, in Europe earlier, with much higher amounts of the drug, without any ill effects. That is why we are also interested in exploring the higher dose level , since it might be more effective at helping people stop drinking, and since this is the first time a stronger tablet of acamprosate has been available.
  • The only side effect that consistently appears to occur more often with acamprosate than with placebo is loose stools , and that occurred in fewer than 10% of patients participating in European multicenter trials and was only rarely the reason for discontinuation of medication.

A. MEDICATION ISSUES (continued)

  • Acamprosate is not habit forming, addicting, or mood altering , and patients do not become tolerant to its effects.
  • Acamprosate does not interact in a harmful way with alcohol or other drugs used to treat alcohol dependency (like AntabuseĻ or ReViaĻ) or with commonly prescribed drugs for anxiety (like barbiturates, benzodiazepines).
  • Acamprosate is safe to take and may be helpful for achieving a treatment goal of abstinence.

2.Patient Skips or Forgets to Take Medication

NOTE: The patient should be instructed at study onset, not to remove tablets from their blister packing if a dose (or part of a dose) is missed or skipped, because it is important for the site to see when a dose (or part of a dose) was not taken.

If the patient skips or forgets to take his/her medication , the following information can be given:

  • Educate the patient about how acamprosate works , with suggested dialogue, as follows:
  1. It takes 5 days of consistent use to achieve a steady therapeutic level of medication circulating in your blood. For you to get the benefit of medication to support your treatment goal of abstinence, the medication must be taken consistently, as prescribed.
  2. The medication can only help you to maintain abstinence if you take it consistently, like an antibiotic. It does not work like an aspirin, to be taken only on those occasions when you feel you need it.

A. MEDICATION ISSUES (continued)

  1. Ask the patient about past experiences with multiple doses of daily medication:
  • What helped him/her to remember to take medication?
  • What interfered with remembering to take medication?
  1. Problem solve with patient
  • Suggest taking medication at a set time of day (e.g., first thing in the morning and just before going to bed--perhaps when they are brushing their teeth in the morning and evening).
  • Suggest involving others, e.g., to witness or administer the medication.
  • Place post-it notes or other reminders in prominent places.

NOTE: If more than six hours has elapsed since a missed dose, this missed dose should be skipped and the next dose taken as regularly scheduled.

3.Part of a Dose Has Been Lost or Misplaced

If the patient loses or misplaces part of a dose of study medication (e.g., drops and/or loses a pill), he/she should be instructed to take a pill from the extra medication doses provided, following a vertical column from the missed pill location to select the appropriate replacement pill.

4. Patient Loses Entire Blister Pack

If the patient loses an entire blister pack, but has additional study medication packs available , he/she should be instructed to start with the appropriate day and time of day (morning or evening), using the next numbered medication packet. The site should telephone Lipha Pharmaceuticals, Inc. (Mr. Bruce Goddard) for further instructions and/or for replacement of medication, if necessary, at 1-800-LIPHA 9W ( 1-800-547-4299 ).

A. MEDICATION ISSUES (continued)

If the patient loses an entire blister pack and no additional study medication packs are available, Lipha Pharmaceuticals, Inc. (Mr. Bruce Goddard) should be telephoned at once 1-800-LIPHA 9W ( 1-800-547-4299 ).

5.Patient Is Concerned That He/She Is on Placebo

If the patient is concerned that he/she is on placebo, reassure the patient as follows:

  • There is a greater chance than in most double-blind studies that the patient is on active medication, because there are more people assigned to treatment with acamprosate than placebo --so the odds of being on active drug are in their favor.
  • The absence of side effects does not mean that they are on placebo: in fact, 90% of patients taking acamprosate report no side effects at all .
  • It takes time for the medication effect to develop. This can occur more slowly in some patients and it is important to keep taking the medication as prescribed and to continue trying to maintain abstinence .

6.Patient's Alcoholics Anonymous (AA) Group Does Not Support the Use of Medication

  • Provide patient with the brochure entitled, The AA Member-Medications and Other Drugs, and refer the patient to the section that indicates that no AA member "plays doctor".
  • Remind the patient that there are many routes to achieving abstinence and that this treatment program, appropriate medication (such as the study drug) and AA may all be helpful in meeting a treatment goal of abstinence.
  • Explore the possibility of participating in and attending other AA groups that are more tolerant of appropriate use of medication.

A. MEDICATION ISSUES (continued)

  • Reassure the patient about the safety and non-addicting properties of acamprosate ( see also above section A.1 on Patient Concerns... ).
  • Inform the patient that the AA Central Office has issued a statement encouraging patients to participate in alcoholism research .

B. ALCOHOLICS ANONYMOUS (AA)

Alcoholics Anonymous (AA) has often been a part of a patient's experience and, for many, AA may be a viable part of their plan to maintain abstinence.

Sites should seek to identify AA meetings that are supportive of appropriate use of medication . Patients should be given contact information for such meetings that are located in close proximity to their home and work or school.

NIAAA's Twelve Step Facilitation Therapy Manual , developed for Project MATCH, may be helpful for learning phrases and key concepts of AA.

It is also recommended that study therapists attend an open AA meeting, an Al-Anon meeting, and develop a network of AA contacts: men and women who are active in AA and who could be called upon to give advice about particular meetings, provide directions, etc. ( These names and telephone numbers can be listed on your Local Outreach Telephone Number card ). Therapists can develop such working relationships by going to AA meetings or talking with recovering persons they know.

Information about AA should be provided to the patient at the Baseline/Randomization (Visit 0) brief intervention session, and attendance at AA is to be asked about at each session thereafter and recorded in the CRF ( Concomitant Psychosocial Therapy Page at each visit ).

For patients who express concern about AA's views on participation in alcoholism research, reassure them that the Central Office of AA has released a statement supporting such activities.

C. PATIENTS WHO ARE DISSATISFIED WITH THE TREATMENT

Patients may report thinking that the assigned treatment is not going to help or may indicate that they want a different treatment. Under these circumstances, you should first reinforce patients for being honest about their feelings (e.g., "I'm glad you expressed your concerns to me right away." ).

You should also confirm that patients have the following rights:

  • to quit treatment at any time,
  • to seek help elsewhere,
  • to decide to work on the problem on their own.

In any event, you should explore the patient's feelings further (e.g., "Whatever you decide is up to you, but it might be helpful for us to talk about why you're concerned" ).

1. When Concerns Arise during the First Session

Concerns of this kind that arise during the first session are probably reservations about an approach they have not yet tried . It is appropriate to reassure the patient that you will be offering all the help you can.

No one can guarantee that any particular treatment will work, but you can encourage the patient to give it a good try for the planned period and see what happens.

You can add that should the problem continue or worsen, you will discuss other possible approaches and options.

C. PATIENTS WHO ARE DISSATISFIED WITH THE TREATMENT (continued)

2. When Concerns Arise after Two or Three Sessions

If a patient expresses reservations after two or three sessions, consider whether there have been new developments, such as:

  • Have new problems, related to drinking, arisen? 
  • Did the plan for change that was previously developed with the patient fail to work, and if so, why? 
  1. Was it properly implemented? 
  2. Was it tried long enough? 
  • Is there input or pressure from someone else for a change in approaches or for discontinuation of treatment? 
  • Is the patient discouraged?

3. New Problems Related to Drinking Arise

If the patient's drinking problem has shown improvement but new problems , related to drinking and not previously identified, have appeared, these new problems can be discussed, following (and not departing from) the treatment procedures outlined above .

The discussion of new problems with drinking and related concerns, or a review of how prior implementation failed, can set the stage for continuation in treatment. You can suggest that it may be too early to judge how well this approach will work and that the patient should continue for the 6-month duration.

After that, if the patient still feels a need for additional treatment, he or she can certainly exercise their option to obtain it.

D. MISSED APPOINTMENTS

When a patient misses a scheduled appointment , the situation must be responded to immediately, according to the Patient Follow-up Algorithm for a Missed Visit ( Pg. 17 of ACAMP/US/96.1 Protocol and also in the Telephone Log Book ) . [9]

As per the algorithm, study site personnel must first try to reach the patient by telephone, within 24 hours of the missed visit

1. If Contact with the Patient is Made

If contact is made with the patient, the following basic points should be covered  (ideally, by the therapist):

  • Clarify the reasons for the missed appointment.
  • Affirm the patient- reinforce for having come.
  • Express your eagerness to see the patient again.
  • Briefly mention serious concerns that emerged and your appreciation ( as appropriate ) that the patient is exploring these.
  • Express your optimism about the prospects for change .
  • Reschedulethe appointment.

If no reasonable explanation is offered for the missed appointment (e.g., illness, transportation breakdown), explore with the patient whether the missed appointment might reflect any of the following:

  • Uncertainty about whether or not treatment is needed(e.g., the patient may state-- "I don't really have that much of a problem" );
  • Ambivalence aboutmaking a change ;
  • Frustration or anger abouthaving to participate in treatment (particularly if patient has been coerced by others into entering the program).

D. MISSED APPOINTMENTS (continued)

Handle such concerns in a manner consistent with reflective listening and reframing the concerns . Indicate that it is not surprising, particularly in the beginning phase of consultation, for people to express their reluctance ( or frustration, anger, etc. ) by not showing up for appointments, being late, and so on.

Encouraging the patient to voice these concerns directly may help to reduce their being expressed in future missed appointments .

Affirm the patientfor being willing to discuss concerns.  Then summarize what you have discussed, adding your own optimism about the prospects for positive change, and obtain a recommitment to treatment. (It may be useful to elicit some self-motivational statements from the patient in this regard.)

Finally, reschedule the appointment.

2. If Contact with the Patient is Not Made

If you cannot reach the patient by telephone, proceed with the Follow-up Algorithm for a Missed Visit .

The algorithm specifies that a registered letter [10] be sent if phone contact cannot be made with the patient or collateral informant.

Research indicates that a prompt telephone call and letter (if necessary) significantly increase the likelihood that the patient will return (Nirenberg et al. 1980; Panepinto and Higgins 1969). Place a copy of the letter in the Telephone Log Book.

E. THERAPEUTIC TELEPHONE CONSULTATIONS

Some patients and their collateral informants may contact you by telephone between sessions for additional consultation. In such cases, the following procedures should be followed:

  • All such contacts should be carefully documented in the patient's file.
  • An attempt should be made to keep such contacts brief, rather than providing additional sessions by telephone.
  • All telephone contacts must also comply with the basic procedures of the brief intervention, as follows:
  1. Specific change strategies should not be prescribed.
  2. Rather, your approach emphasizes elicitation and reflection.

Early in a telephone contact, you should comment positively on the patient's openness and willingness to contact you. Reflect and explore any expressions of uncertainty and ambivalence that are expressed with regard to goals or strategies discussed in a previous session.

It can be helpful to "normalize" ambivalence and concerns ; by saying, for example:

"What you're feeling is not at all unusual. It is really quite common, especially in these early stages. Of course you are feeling confused. You are still quite attached to drinking, and you're thinking about changing a pattern that has developed over many years . Give yourself some time! "

Also, reinforce any self-motivational statements and indications of willingness to change .

Reassurancecan also be in order during these brief contacts, e.g., that people really do change their drinking, often with a few consultations.

F. STRATEGIES FOR HANDLING A DRINKING "SLIP" OR EVIDENCE OF ILLICIT DRUG USE

It is anticipated that, during the course of the study, some patients (hopefully, primarily those on placebo) will drink. It is also quite likely that some patients will show evidence of illicit drug use during the study, and it is important that a uniform strategy be used for all patients (drinkers and abstainers, patients occasionally using illicit drugs) in order to allow medication effects to be demonstrated.

If the patient (or the collateral informant) reports that they have had a "slip" to some drinking or if there is evidence of illicit drug use (as by a positive urine drug screen), avoid recommending additional AA meetings or other concomitant psychosocial therapies. NOTE: In fact, attendance at 12-step programs is not a requirement of the protocol and at no time, after Baseline, should the recommendation be made by site personnel for the patient to attend additional 12-step meetings (e.g., as in the case of a slip or relapse to drinking or with illicit drug use). 

Acceptable strategies if the patient drank or used illicit drugs since the last session include a discussion of how the drinking/drug use occurred , keeping the following points in mind:

  • Remember to remain empathic and to avoid a judgmental tone or stance.
  • Do not prescribe coping strategies for the patient;
  • Use the discussion to renew motivation , eliciting the patient's thoughts, feelings, reactions and realizations . Key questions can be used to renew commitment, such as the following:

"So what does this mean for the future?," and

"I wonder what you will need to do differently next time?"

F.STRATEGIES FOR HANDLING A DRINKING "SLIP" OR EVIDENCE OF ILLICIT DRUG USE (continued)

Patients may also find it helpful and rewarding to review situations in which they might have drunk or used illicit drugs previously , or in which they were tempted to drink or use drugs but did not do so:

  • Ask patients to clarify what they did to cope successfully in these situations.
  • Give praise for small steps toward success, even minor progress or improvement.

The exploration of relapse situations may lead into several relevant areas of further discussion and exploration :

  • For individuals experiencing considerable guilt over a relapse, the therapist can offer supportive statements and information, such as the following:

"It is not unusual for people to have a slip when they first try to quit. What is important is that they try to evaluate what happened and what changes they need to make to reduce the risk of it happening again. You deserve a lot of credit for catching that slip before it got too far out of hand."

  • Discussion of a relapse episode may also unveil a patient's uncertainty over abstinence as their intended goal . In such instances, the therapist should emphasize that while we advise and encourage abstinence as a goal, it is ultimately up to the patient to decide.
  • A related issue may be slips in which the patient consumes light or moderate levels of alcoholic beverages or uses a small amount of an illicit drug (e.g., occasional marijuana smoking). In these cases, it is important to reinforce the patient's restraint but also advise the patient of the potential risk of even moderate consumption levels.

F.STRATEGIES FOR HANDLING A DRINKING "SLIP" OR EVIDENCE OF ILLICIT DRUG USE (continued)

  • Finally, the exploration of relapse situations may reveal considerable resistance to the abstinence goals of the study . It is very important that the therapist not be seen as a judge so the patient continues to be willing to return to talk about the frustrating and embarrassing experience of slipping or relapsing. Suggested dialogue, in these cases, includes the following:

"It is up to you what you do about this. No one can decide for you."

"Successful abstinence is a safe choice. If you do not drink, you can be sure that you will not have problems because of your drinking. There are good reasons to at least try a period of abstinence (e.g., Your ability to think is likely to improve . Heavy drinking over a long time dulls the mental abilities important for learning new skills; these abilities sharpen again after 2-3 weeks of abstinence)." < /span>

"You will discover how you cope spontaneously (on your own) with urges or temptations to drink. This will make it easier for you to accomplish whatever goal you select."

"No one can guarantee a safe level of drinking that will cause you no harm, because you are dependent on alcohol.

Remember, just as when you address other lifestyle areas, such as obesity, many patients will not act on your advice immediatelyMonitor their progress. Also, keep in mind that patients may reduce their drinking for a time, then slowly fall back into old behaviors. Progress must be continuously monitored.

F. STRATEGIES FOR HANDLING A DRINKING "SLIP" OR EVIDENCE OF ILLICIT DRUG USE (continued)

In summary, in the event of a slip or evidence of gradually increasing alcohol consumption, you, as therapist, should:

  1. Restate your concern.
  2. Reinforce your support and willingness to help.
  3. Provide feedback.
  4. Monitor the patient's progress.

In the case drinking has resumed at a level consistent with treatment failure ( as defined on Page 58 of the Protocol ACAMP/US/96.1 ), the patient is to be terminated from further study participation, following the appropriate procedures (including completion of all Visit 8 evaluations and filling out the Termination/Completion of Treatment Phase form). The patient should also be referred for more intensive treatment , rather than augmenting the study's brief intervention procedures.

G. THE PATIENT WHO CONTINUES TO DRINK

An important and consistent message throughout treatment is the patient's responsibility and freedom of choice . Reminders of this theme should be included during the commitment-strengthening process , using the following types of commentary:

  • It is up to you what you do about this.
  • No one can decide this for you.
  • No one can change your drinking for you. Only you can do it.
  • You can decide to go on drinking just as you were or to change .

1. Review of the Consequences of Action and Inaction

A useful strategy is to ask the patient to anticipate the result if the patient continues drinking as before, to include the following points:

  • What would be likely consequences ?  ( It may be useful to make a written list of the possible negative consequences of not changing. )
  • What are the patient's thought on the anticipated benefits of change ?

For a more complete picture, you could also discuss what the patient fears about changing:

  • What might be the negative consequences of stopping drinking, for example?
  • What are the advantages to drink as before?

Use reflection, summarizing, and appropriate therapist responses.

You might consider helping the patient construct a " risk/benefit analysis " or " decisional balance ", by having the patient generate (and write down) the pros/cons and change options: What are the positive and negative aspects of continuing drinking as before?  What are the possible benefits of making a change in drinking?

H. COLLATERAL INFORMANTS

1. General Information about the Collateral Informant's Role

A close friend or relative should be identified by the patient who is willing and able to report on the patient's drinking and/or verify drinking information reported by the patient. This person must be aware of the patient's drinking behavior and day to day habits in this regard, and must be able to be contacted by telephone and/or beeper. A back-up collateral informant should also be specified in the event the original collateral informant becomes unavailable during the course of the study.

The purpose of a collateral informant is only to provide verification of the patient's self report and should not be involved in conjoint therapy for the purposes of this protocol. In addition, if the patient fails to appear for a scheduled visit or cannot be contacted during a scheduled telephone follow-up, attempts will be made to contact the collateral informant for assistance and/or information ( following the Algorithms on Pages 17 and 18 of the ACAMP/US/96.1 Protocol, also in Telephone Log Book ).

Any discrepancy between the patient and collateral informant report of alcohol use should be resolved as it arises. If agreement cannot be reached, the most negative report should be assumed to be accurate and entered into determination of the Clinical Global Impression.

Ideally, the initial meeting with the collateral informant at the Baseline/Randomization Visit (Visit 0) would be in person . However, subsequent scheduled contacts may be in person or by telephone . At selected visits, the collateral informant will also be completing the DrInC-2R-SO interview. Ideally, and certainly whenever possible, the collateral informant should be interview prior to the patient's scheduled visit.

H. COLLATERAL INFORMANTS (continued)

Avoid requesting inputfrom the collateral informant in formulating treatment goals and developing a plan of action . Do not request or expect collateral informant affirmation of decisions made by the patient with regard to drinking and change.

2. Collateral Informants Who Request Help with the Patient

If the collateral informant has indicated a need for support in relation to the patient's drinking, ask the patient's collateral informant if she/he would be willing to attend an Al-Anon meeting . If the answer is yes , provide an Al-Anon Family Group meeting schedule and take a minute to identify two or three meetings that might be convenient to where she/he lives or works or goes to school.

Introduce Al-Anon as a fellowship of men and women who are in relationships with alcoholics and who gather in order to take care of themselves and seek support for their own growth process.

Going to an Al-Anon meeting does not imply any blame for the alcoholic's problem drinking; on the contrary, Al-Anon was originally formed by spouses of alcoholics in order to help them learn to detach from any feelings of shame or guilt associated with their partners' illness. Meetings are anonymous, there are no fees, and the only condition for membership is being in a relationship with an alcoholic.

If the collateral informant expresses reservations about Al-Anon, explore these by asking what questions she/he has or concerns that would stop him/her from trying Al-Anon. Typical concerns are:

"What kinds of people will I find there?"

Answer: All kinds of people, some like you and some not like you. What you all have in common is being in a relationship with an alcoholic.

H. COLLATERAL INFORMANTS (continued)

"What will I be expected to do?"

Answer: You are not required to do anything. You can just go and listen and see if listening to others who are in or have been in the same boat as you is helpful to you in any way. If you want to, you can talk to some of the other people who are there after the meeting is over.

"What is the benefit of Al-Anon?"

Answer: Living with an alcoholic is like living with anyone who has a chronic illness-it affects not only the person with the illness, but those around her/him. Over time, their lives get out of control too, and they often experience stress or depression, not to mention frustration. They often do not know the right thing to do. The best source of help for these people is others who have had to deal with similar situations. Al-Anon offers a program for starting to take care of yourself instead of everyone else.

"What will I be committing myself to?"

Answer: Nothing. We are asking you to try out Al-Anon, not to commit to it. If you do not think it is helpful, just stop going.

Despite this reassuring information, some collateral informants may resist making a commitment to Al-Anon even after all of their questions have been answered. Others may simply refuse to consider it . Do not pursue the issue beyond eliciting concerns and questions and answering them as best you can.

Probably the most common therapeutic complication will be the patient's reaction (s) to the involvement of the collateral informant in Al-Anon. This is where detaching needs to be conceptualized as a reciprocal process .  Namely, not only must partners detach from alcoholics and allow them to be responsible for their own recovery, but alcoholics must also allow their collateral informants to take care

H. COLLATERAL INFORMANTS (continued)

of their needs and issues, including how alcoholism has affected them and how they should act in the future.

The therapist should try to be an advocate of both the collateral informant's right to take responsibility for her/his own issues and to seek the support and guidance of peers.

I. CRISIS INTERVENTION

If at any time, in the therapist's opinion, the immediate welfare and safety of the patient or another person is in jeopardy (e.g., impending relapse, patient is acutely suicidal or violent), the therapist must intervene immediately and appropriately for the protection of those involved. ( NOTE: The Local Outreach Telephone Numbers card will provide emergency/crisis contact information ).

As noted above, the therapist's involvement in crisis interventions cannot exceed two sessions above and beyond those prescribed by the study protocol . If a patient's urgent needs require more additional treatment than this, based on his/her own evaluation and the defined procedures of the study, the therapist should consult with the LIPHA Medical Monitor at 1-800-LIPHA 9W (1-800-547-4299) to determine what action is warranted and whether the patient should be continued in the study, or referred for more intensive treatment.

REFERENCE LIST

Alcoholics Anonymous (AA)

The A.A. Member - Medications and Other Drugs.

The A.A. Grapevine, Inc., Alcoholics Anonymous Worldwide Services, Inc., New York, NY, 1984

Bien T.H., Miller W.R., Tonigan J.S.

Brief interventions for alcohol problems: A review.

Addiction, 1993, 88:315-336

Miller W.R., Zweben A., DiClemente C.C., Rychtarik R.G.

Motivational Enhancement Therapy Manual. A Clinical Research Guide for Therapists Treating Individuals with Alcohol Abuse and Dependence.

NIH Publication No. 94-3722 (1994)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The Physicians' Guide to Helping Patients with Alcohol Problems.

NIH Publication No. 95-3769 (1995)

Nowinski J., Baker S., Carroll K.

Twelve Step Facilitation Therapy Manual. A Clinical Research Guide for Therapists Treating Individuals with Alcohol Abuse and Dependence.

DHHS Publication No. (ADM)92-1894 (1992)

Sanchez-Craig M., Wilkinson D.A.(1989)

Brief treatments for alcohol and drug problems: Practical and methodological issues.

In (Eds. T. Loberg, et al)., 1989 Addictive Behaviors. Prevention and Early Intervention .



[1] The content of the sessions is based on The Physicians' Guide to Helping Patients with Alcohol Problems that was developed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for use in primary care settings and the Motivational Enhancement Therapy Manual developed under the aegis of NIAAA for Project MATCH.

[2] If the patient fails to bring the completed Drinking Diary covering the previous interim period at any visit or has failed to fill it out consistently, the therapist should conduct the TLFB interview in the usual manner, using the calendar and highlighting special dates, special events, weekends, drinking patterns, etc.

[3] In these sections, suggested or possible dialogue is shown in italicized text and slightly indented.  Instructions to you or comments on possible courses of action to take are shown in bold or are italicized and bolded.

[4] These would include the Alcohol and Substance Use History (Pgs 11-13 of CRF), Treatment Utilization (Pg 14 of CRF), Concomitant Psychosocial Therapy (Pg 15 of CRF), Alcohol Dependence Scale (ADS)(Pgs 16-17 of CRF), DSM IV for alcohol dependency (Pg 18 of CRF), as well as the Social/Employment Information (Pgs 2-3 of CRF),

[5] The TLFB will either be done by the therapist or other qualified site personnel.

[6] This sheet is located in each individual study patient's section of this manual.

[7] Multiply number of drinks per week, derived from the TLFB, by: 1) $1.25 for weekly home drink cost, 2) estimated local bar per drink cost for weekly bar-drinking cost; and , 3) 100 calories per drink for weekly caloric intake from alcohol.

[8] The TGW, on 2-part NCR paper, can be found in each individual study patient's section of this manual and extra copies are available in tablet form.

[9] A separate, similar algorithm is to be followed in the event that a scheduled telephone contact with the patient is not made (Patient Follow-up Algorithm for a Missed Telephone Contact, Pg. 18 of the ACAMP/US/96.1 protocol and also in the Telephone Log Book).

[10]   A sample letter, which can be tailored to the specific situation, is included in the Telephone Log Book.