Behavioral Drug and Risk Reduction Counseling (BDRC) for HPTN058 TREATMENT MANUAL

Transcription

1 BDRC Treatment Manual for HPTN058 July 2010 Behavioral Drug and Risk Reduction Counseling (BDRC) for HPTN058 TREATMENT MANUAL Marek C. Chawarski, Ph.D. Declan T. Barry, Ph.D. Mahmud Mazlan, M.D. Richard S. Schottenfeld, M.D. Yale University School of Medicine New Haven, Connecticut Substance Abuse Center, Muar, Malaysia

2 BDRC Treatment Manual for HPTN058 July 2010 Page 2 Manual for Behavioral Drug and Risk Counseling (BDRC) for Opioid Dependent Individuals enrolled in HPTN058 study protocol Table of Contents TOPIC PAGE Introduction 3 I. Treatment Philosophy of BDRC A. Overview 3 B. Typical features of opiate dependent patients 3 C. Theory and treatment philosophy 5 II. General Aims of the Therapeutic Intervention 8 III. Therapeutic Components of BDRC 9 IV. Counselor s Specific Aims During BDRC 11 V. Sequence of BDRC sessions 12 VI. Format of BDRC 13 VII. Introduction to Counselor s Handbook 15 Phase One of BDRC 15 Phase Two of BDRC 44 BDRC Materials Appendix IA BDRC Contract Appendix IB Relapse Prevention Exercise Appendix IC PTPE Exercise

3 BDRC Treatment Manual for HPTN058 July 2010 page 3 Introduction This manual contains guidelines and recommendations for implementing Behavioral Drug and HIV Risk Counseling (BDRC) for use in the HPTN 058 Phase III randomized controlled trial to evaluate the efficacy of drug treatment in prevention of HIV infection and death among opiate dependent injectors. The purpose of HPTN 058 is to determine the efficacy of a drug treatment intervention involving administration of a buprenorphine/naloxone (BUP/NX) combination for 52 weeks plus drug and risk-reduction counseling (hereafter referred to as Long Term Medication Assisted Treatment compared with short-term Medication Assisted Treatment with BUP/NX plus drug and riskreduction counseling (hereafter referred to as Short Term Medication Assisted Treatment) for the prevention of HIV transmission and death among opiate dependent injectors by reducing drug use and associated risk behaviors. The Study Population will consist of approximately 1500 HIV-uninfected, opiate dependent injection drug users who meet the eligibility criteria. The total duration of the study will be approximately four and a half years. Participants will be followed for a minimum of 104 weeks and a maximum of 156 weeks, depending on when they are enrolled. Behavioral and serologic assessments will take place at baseline and at 26 week intervals throughout the follow-up period. Eligible, HIV-uninfected opiate dependent study volunteers will be randomized to one of two study arms in a 1:1 distribution. Counseling in both study arms will use drug and risk-reduction counseling adapted from evidence-based interventions and adapted by the sites. This counseling strategy will be delivered by trained addiction/prevention counselors and will focus on achieving and maintaining individualized goals of drug use reduction and HIV prevention. All study procedures must be consistent with the latest versions of the Protocol and the Study Specific Procedures Manual (SSP). Counseling and medication management begin together at randomization, with visits occurring at the same time and in the same facility as often as possible to reduce participant inconvenience and increase compliance. Clinicians and the counselors should consult each other regularly about the participant s overall progress in study treatment; however, each treatment modality proceeds according to its specified procedures as stated in the protocol, in the Study Specific Procedures Manual (SSP), and in the respective treatment manuals. Clinicians and counselors should become familiar with both the counseling and BUP/NX manuals so that the treatment of the participant will be coordinated. In HPTN 058, BDRC includes twelve weekly 45 minute sessions followed by ten monthly sessions through study week 52. All sessions are delivered in the individual format (i.e., oneon-one; typically, the same counselor provides all 22 BDRC sessions to the same study participant) in the appropriate clinic settings (i.e., counseling rooms affording privacy, confidentiality, and sufficient comfort to conduct minutes of uninterrupted discussions). BDRC sessions are delivered by drug counselors, nurses, medical assistants or other qualified personnel after they successfully complete a study specific BDRC training. In addition to individual sessions, the BDRC counselor should encourage the participant to engage in any available additional drug treatments or counseling services available in the community, including

4 BDRC Treatment Manual for HPTN058 July 2010 page 4 self-help or peer support groups therapy or peer counseling. Sites are encouraged to support organization/establishment of peer counseling groups if no self-help, peer support groups are available. BDRC is highly structured and prescriptive. It focuses on a limited set of immediate problem areas including treatment participation and medication adherence; becoming abstinent, maintaining abstinence, and preventing relapse; modifying or eliminating behaviors that increase the risk of contracting blood borne or infectious diseases (e.g., HIV, Hepatitis, sexually transmitted diseases); increasing engagement in non-drug-related social interactions and pleasurable activities. In BDRC, the counselor educates the patient about opiate addiction as a chronic medical condition and its optimal treatments while guiding the patient through the initial stages of the recovery process. In addition to cognitive-behavioral counseling techniques, BDRC uses explicit contracting procedures to engage the patient in a straightforward and structured recovery which involves medications (either short- or long-term depending on study arm), counseling, engagement of the participant in clean and sober activities, and promotion of lifestyle changes supportive of sustained abstinence and elimination or reduction of behavioral risks. BDRC puts strong emphasis on prevention of bloodborne and infectious diseases (HIV, Hepatitis, STDs) by increasing patient knowledge of drug and sex related transmission/infection risks and teaching effective prevention strategies. BDRC also educates the patient about effective use of all treatment components and advocates the use of other available resources (e.g., psychiatric, medical, social work, community resources) to maximize the overall effectiveness of the current treatment and to promote a sustained long-term recovery from drugs. I. Treatment Philosophy of BDRC A. Overview An opiate dependent patient is suffering from a chronic relapsing illness that affects his/her physical, emotional, and social functioning, as well as his/her relationships with family and friends, the larger community, and the society. BDRC targets multiple areas of needs for the client in a comprehensive but focused manner. BDRC incorporates the disease model of opiate dependence and is compatible with medication treatments for this disease. It utilizes behavioral change and skills-learning techniques that have proven to be highly effective in initiating and maintaining prolonged abstinence from illicit substances and in fostering a lifestyle supportive of sustained recovery from drugs and elimination of behavioral risks of bloodborne and infectious diseases (HIV, Hepatitis, STDs). In addition to the skills-learning and relapse-prevention procedures commonly utilized in cognitive-behavioral and other drug counseling approaches, BDRC makes extensive use of short-term behavioral contracting and activation procedures to address the core problems associated with opiate dependence and to supplement the counseling sessions with guided exercises aimed at practical application of the newly learned skills in the patient s natural environment. The treatment is designed to provide education about medical conceptualization of opiate addiction and available effective treatments, to increase the patient s activity levels and engagement in rewarding activities not related to drugs, to increase the patent s self-efficacy, and to counter the patient s belief that his/her actions will not lead to success in accomplishing goals. The accomplishment of simple contracts targeting short-term behavioral goals early in

5 BDRC Treatment Manual for HPTN058 July 2010 page 5 treatment promotes the patient s experience of therapeutic success and increases the likelihood of ongoing treatment adherence. In common with other drug counseling approaches, BDRC helps the patient to cope with the symptoms of drug dependence and related areas of impaired functioning, gives the patient improved coping strategies and tools for recovery, assists the patient in achieving and maintaining abstinence from drugs and risk behaviors, and guides the patient in recovery from the damage the addiction has caused in his or her life. B. Typical features of opiate dependent patients. Prolonged use of opiates inevitably leads to an increasing focus on drugs as the most important, or only, reward and reduced engagement in positive pro-social and non-drug-related activities, such as employment, education, family and other social involvement, or non-drug related pleasurable activities (e.g., hobbies, sports, or other interests). Hallmarks of drug dependence include preoccupation with obtaining and using the drug, spending increased time in drug use and drug-related activities, continuing to use drugs despite adverse consequences, and a loss of control over drug use (e.g., inability to stop or refrain from use, using more than intended and more often than intended). Individuals with opioid dependence generally experience repeated failures at achieving important life goals and at fulfilling their roles, responsibilities and obligations to family members, friends or others. Most have also failed repeated attempts to become abstinent, either on their own, or through detoxification or other treatment. Consequently, they often come to believe that they are not capable of accomplishing their own important life goals. Attempts to enter treatment are often extrinsically motivated by mounting legal, financial, health, or family problems. Treatment programs are seen as safe, temporary havens from the storm, but not as opportunities to take an active role in significantly changing lifestyle or activities. This lack of internal motivation and passivity contribute to treatment failures, which, in turn, further reduce an individual s sense of self-efficacy or perceived ability to effect change in his or her life. This combination of lifestyle dominated by opiate use and repeated failures contributes to demoralization and the belief that one s own efforts will not be effective and are not related to success or failure. Feelings of disappointment about past failures and shame are common among patients with opiate dependence. Many patients often feel down or depressed, don t have very much energy, and have difficulties sustaining work or other activities. They appear to have given up on many fronts, including the possibility of ever achieving or sustaining abstinence from illicit substances or significantly improving their lives. They feel resigned and powerless to do anything to succeed or to make things better for themselves. Extended use of illicit opiates and the development of physiologic dependence result in the need to constantly monitor immediate physiological, bodily and emotional signs of intoxication or withdrawal leading to the development of a specific cognitive/thinking style characterized by an external locus of control, extremely constricted time perspective and discounting of future rewards and overvaluation of immediate rewards. External locus of control (i.e., inability to see positive and negative consequences of his/her own actions associated with a belief that the environment, other people, or some higher power control their decisions and their life is often accompanied by unspecified or unrealistic hopes about the future. Many opiate dependent patients hope for a quick dramatic change in their lives at the onset of their current recovery

6 BDRC Treatment Manual for HPTN058 July 2010 page 6 attempt brought about by the treatment or other external circumstances. For example, the patients may believe that simply by taking study medication (Suboxone) they will rapidly become abstinent from illicit drugs or they may hope to win the lottery or obtain a very profitable job and thus solve current legal, financial, or family problems. At the same time, they often lack specific and realistic plans for achieving recovery goals, and their outlook in life is characterized by an encapsulated or constrained perspective (i.e., self-centered, with a narrow scope, and spanning a relatively short time). Typical features of opiate dependent patients, such as shame and guilt about their past actions, blaming others for current life problems; having little energy or initiative outside of obtaining and using drugs; engaging in a very restricted range of activities; believing in an external rather than internal locus of control and perceiving that success is not related to personal activity; and focusing on immediate relief of dysphoric states rather than longer term goals, make it difficult for these patients to engage actively and persistently in recovery activities and interfere with their ability to succeed in substance abuse treatment. BDRC uses cognitive-behavioral techniques to help patients overcome many of these hindrances to help them better engage in their own recovery and to succeed in achieving overall treatment goals. C. Theory and treatment philosophy BDRC uses educational, cognitive, and behavioral techniques to address the key cognitive biases, dysfunctional behaviors, and recovery misconceptions of opiate dependent patients entering a substance abuse treatment program. BDRC offers the patients a conceptualization of opioid dependence that encourages their participation in a structured treatment program; utilizes short-term behavioral contracts to help them accomplish immediate steps leading to abstinence, life style change, and recovery; fosters development of improved self-efficacy and self-esteem; and teaches patients problem solving and cognitive and behavioral skills needed to prevent relapse. To encourage participation in a treatment program offered in the HPTN 058 study, BDRC offers the patient a conceptualization of opiate addiction as a chronic medical condition with a high rate of reoccurrence (or relapse) that can be successfully treated (managed) utilizing a longterm, comprehensive treatment approach consisting of medication (agonist maintenance), expert therapy (counseling), non-expert therapy (self-help or peer support groups), lifestyle change, and active involvement of the patient in his/her own recovery. An analogy with diabetes is often used. Diabetes is a chronic medical condition treated/managed with medication (e.g., insulin injections); regular visits to medical professionals to monitor progress and alter the treatment regimen if necessary; dietary and lifestyle changes; engagement in support groups; and active patient involvement in monitoring blood glucose levels and adhering to their individual diet and exercise recommendations. A similar understanding of opiate addiction helps to attenuate patients guilt and shame about their past failures, encourages them to understand and participate actively in treatment, helps to change patients unrealistic preconceptions about treatment and to counter the belief that success in treatment is outside of the control of the patient. A common misconception among individuals entering agonist maintenance treatment is that the maintenance medication is the critical or only important ingredient of treatment. Many patients at treatment entry report that drugs have lost all of their appeal; they do not feel high or even

7 BDRC Treatment Manual for HPTN058 July 2010 page 7 good after taking the drug, and they continue to use only to prevent withdrawal symptoms. Therefore, they often view agonist medications, such as Suboxone, as a quick fix or substitute for illicit opiates that will help them to prevent relapse and overcome addiction, independent of other interventions. BDRC emphasizes that opiate addiction should be viewed as a chronic medical condition that has no quick fix. It educates the patient about all necessary treatment components and teaches patients how to best utilize all clinical contacts (e.g., counselors, therapists, doctors, social workers) and available resources (e.g., peer support groups, educational and vocational community resources) to maximize possible gains from treatment. Because of their narrow or constrained time perspective, opiate dependent patients may have particular difficulties engaging and succeeding in a long-term treatment program aimed from the outset at achieving long-range, big-picture goals. At the same time, treatments that rely on patients self-efficacy, motivation, skills, and persistence in fulfilling long-term plans to attain recovery goals may not be appropriate for such patients. For many opiate dependent patients with a long history of drug use, long-term goals may feel overwhelming and discouragingly difficult to accomplish. Thus, BDRC seeks to engage patients in a short-term, rewarding, simple and explicit treatment program with specific, limited and achievable primary objectives. These objectives include achieving an initial short period of abstinence from opiates (measured in days), initiating behavioral changes in their everyday lives and social interactions with non-drug using family and friends, and learning about addiction and how to effectively utilize available treatment options. BDRC uses the current motivational state of patients (extrinsic and short term), rather than attempting to modify it, in order to provide them with a chance to gain a firsthand experience of success in treatment and a rewarding life without drugs. D. Key therapeutic components D.1. Contracts To counter pessimism and to behaviorally activate the patient, BDRC makes use of small-step, short-term, explicit and detailed behavioral contracts between the patient and the therapist as initial steps along the way to accomplishment of longer term goals. BDRC utilizes behavioral contracts to increase the likelihood of the patient s engagement in the prescribed activities. Providing a detailed plan within each contract gives the patient a clear sequence of necessary steps leading to successful goal completion. A BDRC contract is a verbal or written agreement between the patient and the counselor describing the prescribed activity which includes an exact time frame, spanning no more than one to two days, and a clear detailed description of all intermediate steps necessary to successfully accomplish the contracted goal. Typically, during BDRC the counselor makes contracts with the patients for treatment participation (e.g., timely attendance at all scheduled counseling sessions and medication dosing appointments), cessation of drug use (e.g., to refrain from use for one day or a few days), increasing activities or social interactions unrelated to drug use (e.g., spend time with a friend or family member who is not using drugs; engage in a sport, hobby, or recreational activities; or attend a peer support group meeting, if such meetings are available), and increasing work or education related activities. Each contract must be reviewed with the patient in the subsequent session. This review follows the sequence of activities or steps outlined within the contract, starting with the activities leading to the initiation of the contract s first step and ending with an evaluation of the overall contract goal. It is

8 BDRC Treatment Manual for HPTN058 July 2010 page 8 important not to initiate the review with the end goal of the contract. In other words, the counselor should never begin the review with, So, how did it go? or similar questions. Starting with the first step of the contract gives the counselor ample opportunity to provide positive feedback or praise for partial or incremental achievement, or even just good intentions, even in a situation when the overall goal was not accomplished. The patient s failure to accomplish the overall goals of the contract, or some of the intermediate steps, are not extensively discussed or analyzed. Instead, a modified contract, often including smaller and more readily achievable goals and improved strategies to accomplish them, is devised by the counselor and negotiated with the patient. Consistent with the typical patient s expectations about treatment process, external locus of control, and difficulties problem-solving or initiating activity, BDRC is highly structured, explicit, directive and educational. The counselor selects therapeutic goals, decides on the course of actions during treatment, selects solutions to problems encountered by the patient, and makes recommendations about future directions. The therapy is not meant to be exploratory in attempts to understand the wider or deeper context of the specific addiction problems of each patient. BDRC does not require patients to generate potential solutions, or direct the course of the therapy, but it does both permit and encourage patients to become active participants in their own treatment. During the course of BDRC, the counselor and the patient follow a simple explicit plan that demonstrates to the patient how her/his actions can result in positive changes or accomplishments in life. D.2. Positive emphasis BDRC incorporates recent findings from research in cognitive and social psychology suggesting that gain-framed messages are more effective than risk-framed messages in promoting healthprevention activities. Opiate dependent patients with a long history of drug use respond better to acknowledgement of their attempts to change, even if only partially successful ( the glass is half-full ), rather than to a focus on their failures to succeed ( the glass is half-empty ). BDRC, therefore, uses positively framed messages, which emphasize positive consequences of behavioral change (e.g., benefits of not using drugs vs. dangers associated with continued use) and recognizes the importance of the patient s attempts to change. Positively framed or gainframed messages are particularly important for patients who anticipate repeated failures and loss rather than achievement of goals and who are more likely to interpret therapeutic messages in a negative way (e.g., as unhelpful criticism). Research findings also indicate that positively framed advice and recognition or praise for attempts at change generally evoke positive affect, which is often generalized and ascribed to the behavior in question, thus resulting in greater compliance with the message. Viewed from this perspective, some of the approaches often used with patients in drug treatment programs, such as an emphasis on the negative consequences that will result from continued drug use or failure to abide by program rules and expectations, may not be optimal. Consequently, BDRC counselors are trained to provide exclusively positive feedback to patients regarding even the smallest achievements. This emphasis helps patients to build self-esteem and the sense that they can change their lives for the better. D.3. Education and skills training Finally, BDRC teaches patients problem-solving and cognitive and behavioral skills that are

9 BDRC Treatment Manual for HPTN058 July 2010 page 9 helpful in achieving abstinence, preventing relapse, and reducing or eliminating risk behaviors. The focus on problem-solving skills encourages the counselor and patient to identify and harness a patient s existing strengths (rather than focus predominantly on the patient s problems, which may undermine development of self-efficacy) while learning new problemsolving techniques. Later, the focus shifts to having the patient become an increasingly autonomous effective problem-solver. A focus on cognitions and development of competence and skills may be particularly appealing for patients in cultures that do not value open disclosure of emotions (e.g., many cultures in Asia). Skill-building components include sessions focusing on identifying, avoiding and managing or coping with triggers and high risk situations for drug use (e.g., environmental, social or emotional triggers and cues), reducing HIV risk behaviors, and improving day-to-day functioning, including finding pleasurable activities that are alternatives to drug use.. Opiate dependent individuals are at heightened risk for becoming infected with the HIV virus as a result both of injection drug use (injection drug users) and sexual behaviors (both injection and non-injection drug users). Injections of illicit drugs are most often done with non-sterile equipment (needles, syringes, cookers, filters, etc., often reused without proper cleaning), frequently in non-sanitary conditions (such as public restrooms), and some drug users share both drugs and injecting equipment. Drug use may lead to, or facilitate, sexual activity and/or interfere with deciding whether or not to practice safe sex. Sexual activity may also lead to drug use or be used as a means of obtaining drugs or money to buy drugs. Improving knowledge and awareness of the negative consequences of risky behaviors (e.g., reusing or sharing of injection equipment, unprotected sex with strangers) while helping to master alternative safe behaviors promotes effective decision making and problem solving in future situations of potential risks. The goal of BDRC is incremental risk reduction with eventual elimination of these risks. BDRC accomplishes this in two steps: Individualized risk assessment and individualized behavioral modification via contracting combined with skills-learning techniques. Risk assessment involves counselor evaluation of the patient s knowledge of disease transmission, protective behaviors, and risky behaviors, and, in addition, learning about the patient s current behavioral patterns. Behavioral modification puts emphasis on prevention and protection (i.e., engaging in behaviors to protect oneself from further risk, and living a better and longer life), rather than on grave consequences of maintaining unsafe and/or risky behaviors. Patients who currently inject drugs, engage in risky sexual behaviors, or have faulty information or a dearth of information about contraction, exacerbation, and transmission of bloodborne or infectious diseases are viewed as being at-risk. However, all opiate dependent individuals regardless of their currently displayed behavioral patterns of risk or their current knowledge of HIV/Hepatitis/STD transmission are at heightened risk of contracting such diseases. There is clear epidemiological evidence demonstrating that the prevalence of such diseases is overwhelmingly higher in populations of drug users (the most common friends and peers of opiate dependent individuals) than in non-drug users or in the general population. Furthermore, current behavioral patterns of opiate dependent individuals are not indicative of their future risks as behavior and decision making skills can be adversely affected in situations of severe withdrawals or drug intoxication. BDRC equally targets all opiate dependent individuals as recipients of intensive interventions aimed at reduction of risks and improvement of preventive/protective strategies.

10 BDRC Treatment Manual for HPTN058 July 2010 page 10 II. General aims of the therapeutic intervention The stepwise goals of BDRC are to (1) increase patient treatment engagement and improve adherence with medication regimens and all therapeutic treatment components, (2) educate the patient about the disease of opiate dependence and its effective treatments (3) help the patient to reach an initial period of abstinence from drugs, (4) help the patient to reduce or eliminate risk behaviors, (5) activate the patient behaviorally and socially (by increasing interactions with nondrug-using individuals) in order to engage in rewarding or pleasurable activities that are not related to drugs (6) help the patient to master the skills needed to maintain abstinence or reinitiate abstinence after a lapse or relapse, and (7) introduce lifestyle supportive of full and sustained recovery from drug addiction. It is important to maintain the outlined order/hierarchy of the above goals during treatment progression because the accomplishment of each earlier goal is essential to achievement of the next goal. The initial sessions of BDRC seek to engage opiate dependent patients in a rewarding, simple and explicit treatment program with specific, limited and achievable primary objectives. Consequently, the process of learning about or understanding of the patient s presenting problems should focus on the present and be limited to a few content areas. These include current (e.g., within the past week) drug use, work and other everyday activities, social interactions, and immediate goals or plans. Rather than obtaining detailed lifetime history of drug use and associated problems, the counselor s initial focus should be to obtain a fairly detailed snapshot of the patient s current daily lifestyle, in order to be able to devise plans for behavioral changes that can be implemented right from the onset of the treatment. During the initial phase of treatment, which generally lasts from four to six weeks, the counselor and patient also identify longer-term treatment goals and plan specific counseling interventions for the next phase of treatment that can help the patient accomplish these goals. Although patients at treatment entry often report problems or crises in multiple domains of their lives (psychological/emotional, social, legal, economic, and medical), the BDRC therapist is encouraged to eschew extensive exploration of emotional problems (including trauma and stress associated with the patient s life situation) or attempts to resolve for the patient immediate crises (e.g., work, housing, legal, of family crises). Temporarily limiting the focus of therapy to a few, well-defined, and relatively easy to approach problem areas, and delaying attempts to deal with other important issues, may help to decrease stress and counter a typical patent s outlook that change is difficult or impossible due to the multiplicity of their problems. A short-term and restricted focus approach greatly increases the likelihood of the patient experiencing success and having a rewarding experience early in the course of therapy. This, in turn, is likely to decrease symptoms of demoralization, improve motivation, and empower the patient in his/her future attempts at solving bigger, more difficult problems. The focus of BDRC sessions should generally be confined to the following content areas: 1) Adherence with medication regimens and all other treatment components including timely participation in counseling sessions and medication dosing appointments. 2) Education about opiate addiction as a disease, its treatment, and about the role of behavioral change in recovery.

11 BDRC Treatment Manual for HPTN058 July 2010 page 11 3) Means and ways to reduce drug use and achieve abstinence, initially for a short period of time. 4) Means and ways to reduce, eliminate or modify drug- and sex-related risk behaviors associated with transmission of blood borne viruses and other infectious diseases (e.g., HIV, Hep C, STD), including education about these risks and effective prevention strategies. 5) Behavioral activation that helps the patient extricate from a state of inactivity and/or fill in the void created by the abandonment of drug related activities. 6) Development of and engagement in a drug-free network of social support (e.g., non-drugusing family members and friends or peer based recovery programs) to promote social relationships that are supportive of abstinence rather than drug use. 7) Development and strengthening of relapse prevention skills and techniques and advancement of a lifestyle supportive of prolonged recovery from drugs. BDRC should use referrals to other available resources to help the patient deal with other problem areas (e.g., trauma, anxiety, other psychiatric issues, or legal, housing or social service needs). In summary, the goal of the BDRC is to provide the patient with a snapshot of a rewarding life without drugs via patient engagement in a short-term, explicit, and rewarding counseling process. This snapshot of life without drugs is then used to build a larger picture that includes better understanding of the complexity of their substance use problem and development of long term plans for achieving long-term abstinence from drugs a major change in life. A successful course of BDRC therapy leads to the initiation of lifestyle supportive of sustained abstinence including active relapse prevention efforts and engagement in long-term recovery plan. BDRC can be conceptualized as being divided into two phases: the initial BDRC sessions put more emphasis on the patient s active engagement in treatment and achievement of initial behavioral changes; the remaining BDRC sessions (generally after the first month to six weeks of treatment) address the longer-term treatment needs and teach cognitive and behavioral skills needed to avoid relapse and sustain recovery. III. Therapeutic components of BDRC BDRC targets achievement of success early in treatment by setting small, clearly defined, and easily achievable behavioral goals with a focus on positive aspects of recovery. Instead of focusing on general hopes about major changes in life, BDRC encourages patients to focus on specific and well-defined immediate activities that produce small changes. Accomplishment of small changes illustrate to the patient that their actions can be effective and lead to positive results. When attained, small changes are rewarding, improve self-esteem and sense of achievement, help to improve emotional functioning, and reduce guilt and shame. If the patient fails at a small attempt to change, the emotional impact of a small failure is not devastating, and the problems encountered during a failed small attempt are easier to analyze,

12 BDRC Treatment Manual for HPTN058 July 2010 page 12 understand and overcome during the following attempt. The small changes achieved during the course of the therapy serve as the foundation for promoting larger change and are opportunities for the counselor to emphasize that more significant patient change is possible. BDRC is educational and prescriptive: it provides extensive education about opiate dependence and effective medical and psychosocial treatment components, as well as blood borne and infectious diseases, and effective prevention strategies. One of the BDRC counselor s roles is to educate the patient about the medical and psychosocial components of addiction and treatment and effective HIV prevention strategies. The patient s understanding of addiction as a disease that has no quick fix is paramount to success in recovery. Emphasis is also placed on educating the patient about the optimal use of all components of the study treatment (including Suboxone) and clinical contacts with counselors, doctors, or other study personnel in order to maximize the effectiveness of substance abuse treatment offered in HPTN058. BDRC utilizes short-term contracts between the counselor and the patient to increase the likelihood of the patient s engagement and successful completion of prescribed activities. The key therapeutic component of BDRC is a series of behavioral contracts in the form of written or verbal agreements between the counselor and the patient. An important feature of these contracts is the initial focus on realistic, small, and easy to obtain achievements. Examples of small and short-term contracts include timely participation in all medication dosing appointments and counseling sessions, disposing of drug use paraphernalia, not using drugs for a day or two even without a commitment to an extended drug abstinence, changing a daily routine related to the way drugs are obtained or used, or finding temporary/transient employment. At times, these initial achievements may not immediately appear to contribute substantially to the accomplishment of the greater goals (e.g., sustained abstinence and recovery). However, when patients accomplish small, well-defined goals and experience improvements in their mood and sense of efficacy, they are often motivated to engage again in similar, or even more complex, contracts. All contracts use short timeframes (1 to 2 days), target behavioral changes, and include detailed and explicit step-by-step plans. It is the counselor who suggests the most appropriate areas/activities for the contract and guides the patient through the process of developing an action plan that has a high likelihood of achieving the contracted goals. Contracting interactions end with one of two explicit patient commitments: either the patient gives a verbal commitment; or the counselor and the patient compose a written contract, signed by both. In the subsequent session, the counselor reviews the contract fulfillment with the patient, focusing on accomplishments rather than failures, administering as much of positive feedback as possible, and discussing the patient s satisfaction with attempts to meet the contract goals. It is essential to review with the patient each of the therapeutic contracts during the very next counseling session. Counselor s feedback is framed in a positive tone. Contract review follows the step-by-step order of activities that were planned in order to complete the goal of the contract. Starting with the activities leading to the initiation of the contract s first step and ending with an evaluation of the overall contract goal gives the counselor ample opportunity to provide positive feedback or praise for partial or incremental achievement, or even just good intentions,

13 BDRC Treatment Manual for HPTN058 July 2010 page 13 even in a situation when the overall goal was not accomplished. The patient s failure to accomplish the overall goals of the contract, or some of the intermediate steps, are not extensively discussed or analyzed. Instead, a modified contract, often including smaller and more readily achievable goals and improved strategies to accomplish them, is devised by the counselor and negotiated with the patient. The counselor gives the patient strong encouragement and expresses strong positive belief in the possibility of success with the newly developed alternative plan on how to achieve the goal during the next attempt. If the patient is initially unable to fulfill a contract, strong attempts should be made not to abandon the contract s original focus. The counselor should explore with the patient obstacles and potential solutions to overcoming obstacles while aiming to develop a scaled back version of the initial contract proposing simpler, smaller, and easier to accomplish steps and goals. If the goal is not achievable, common sense may suggest walking away from the unsuccessful arena and finding a different and more promising realm. However, switching from goal to goal is counterproductive in effecting behavioral change. Rather than repeatedly attempting the same goal with slightly modified plans or switching goals altogether, progress can be achieved more efficiently by stepping back (scaling down, contracting for a smaller easier to achieve activity) in order to ultimately move forward. If necessary and practical, the BDRC counselor could engage others to help the patient succeed in the initial steps. For example, if the patient agrees to go to a peer-support group meeting but has difficulties in accomplishing this goal (e.g., social anxiety, lack of transportation, planning and scheduling difficulties), a peer-support group member can often help arrange transportation or accompany the patient to the meeting. Ideally, the series of therapeutic contracts progresses from very small goals to larger, more important goals aligned with sustained abstinence from drugs. The premise is to engage the patient in rewarding activities that provide viable alternatives to drug use by using an approach that emphasizes successful completion of small steps. This approach is driven by optimism about the possibility of change, it alleviates demoralization, increases the patient s self-efficacy, and readily motivates continuation to the next, bigger step. The initial series of therapeutic contracts is viewed as providing the patient with glimpses of how continuing treatment could improve his/her psychosocial functioning and recovery. Additional description of the contracting procedures can be found in Attachment X (BDRC Contract). BDRC provides cognitive and behavioral relapse prevention and skills training and guides the patient through the early stages of a comprehensive recovery program. BDRC helps patients to learn effective, problem-solving strategies and coping skills and to make significant lifestyle changes needed to achieve and maintain abstinence and reduce the risks of blood borne viruses and other infectious diseases transmission. BDRC teaches risk reduction techniques, including both knowledge and skills to identify risks and practical abilities to cope with such risks in order to successfully maintain prolonged abstinence and full recovery from drug use. Depending on the availability of medication-friendly self-help, peer supported recovery programs, BDRC also introduces the patient to the programs and encourages

14 BDRC Treatment Manual for HPTN058 July 2010 page 14 participation. Additional description of relapse/risk prevention techniques can be found in Attachments X (Relapse Prevention Exercise) and Y (Places, Things, People, and Emotions Exercise). BDRC involves individualized risk assessment and extensive risk reduction components for all patients. All opiate dependent individuals are at increased risk of engaging in behaviors that may result in HIV infection, sexually transmitted diseases, and/or other serious medical conditions. Risk behaviors that often accompany illicit opiate use include unsafe drug preparation and use practices, sharing of needles and/or injection equipment, and engaging in unsafe/unprotected sex. Individualized assessment of behavioral risks in BDRC should systematically cover 3 (often interrelated) categories of risk associated with opiate use: a) misinformation and lack of knowledge about bloodborne and infectious diseases, including HIV, Hepatitis, and sexually transmitted diseases; b) risks associated with injection drug use; and c) risks associated with sexual behaviors. BDRC counselors should learn about specific patterns of risk behaviors for each patient before devising individualized risk reduction treatment components. Risk evaluation and risk reduction components of BDRRC involve discussing sensitive information. Both the counselor and the patient may not be initially comfortable talking about high risk behaviors. Patients may be embarrassed talking about sex in general, or about their own sexual experiences. They may also be aware that needle sharing or unsafe sex practices may be viewed with disdain by others. In addition, individuals raised in religious families may find discussion of sexual practices uncomfortable or inappropriate. Consistent with the overall BDRC approach, the counselor should make effort to put the patient at ease by providing a clear rationale for discussing a broad range of risk behaviors and be attuned to the patient s verbal and nonverbal reactions, yet all BDRC counselors should uniformly and persistently discuss such behaviors in a calm, nonjudgmental manner with all study participants. BDRRC utilizes the current motivational state of the patient. Changing the motivation of the patient and directing it toward intrinsic motivational state and achievement of big treatment goals (sustained abstinence, permanent restructuring of their social networks, and the development of an alternative lifestyle) is generally difficult, and can rarely be achieved within a short period of time. Initially the BDRC can utilize the patient s extrinsic motivation to enter treatment and the counselor can present participation in the therapy as a break from the current life storm - a safe heaven or vacation from drugs for some period of time - rather than as a long-term treatment commitment or permanent life-style change. Typically, after the patient has experienced some initial successes, accompanied by a reduction in demoralization, his/her outlook of success in the future is improved, which in turns enhances the motivation and promotes sustained effort to achieve long-term treatment goals. Urine toxicology testing in BDRRC. It is recommended that all available urine toxicology tests are utilized in BDRC treatment and their results are discussed during the counseling sessions as objective indicators of the patient progress in treatment. The counselor should introduce drug urine tests as similar to other medical laboratory testing procedures, such as monitoring blood sugar levels for patients with

15 BDRC Treatment Manual for HPTN058 July 2010 page 15 diabetes, rather than means to validate the patient s report of his or her recent drug use. In BDRC sessions, the counselor first shares all available urine test results with the patient before engaging the patient in discussing his or her reports on the current illicit drug use. Negative urine tests are presented and discussed as objective, medical confirmation of the patient progress in treatment. Positive urine tests are used as starting points to discussing ways of achieving better treatment progress, or what additional skills or behavioral changes could prevent future relapses to drug use. Involvement of family, spouses or other significant persons in BDRC. BDRC has been developed as an individual therapy and it is recommended that only one counselor and one patient participate in most, if not all, of the BDRC sessions. However, because we recognize the importance of family, spouses, significant friends and other members of the close social networks in the recovery process, BDRC includes recommendations on how such individuals could be successfully engaged in supporting the patient s recovery efforts. In general, it is recommended that family members, spouses, or other close/important individuals could be offered separate educational sessions, preferably without the participation of the patient who is in treatment. These educational session should focus on the following topics: a) medical understanding of the disease of opiate dependence and its effective treatments; b) the role of medications in effective treatments of opiate dependence (e.g., how medications differ from illicit drugs); c) the role of counseling, explaining and demystifying the counseling process and techniques: d) the role of social support in recovery, including family support, but also participation in self-help groups or organizations. IV. Counselor s specific aims during BDRC: 1. Introduce himself or herself as someone who is knowledgeable in substance abuse treatment, describe his/her role in treatment, explain the treatment components, and outline expectations and rules of conduct during the entire treatment. Establish open and honest communication with the patient. Develop a relationship with the patient where the counselor is perceived as providing expert guidance about opiate dependence/addiction and treatment for this disease. 2. Provide the patient with education regarding medical conceptualization of opiate dependence and its treatment. The counselor should also provide extensive education about health risks associated with drug use, such as unsafe drug preparation and use methods, and unsafe sex practices. Patient education should include information about the role of medications, counseling, and lifestyle changes as important components of an effective treatment and should be provided in language and format that is easily understood and accepted by the patient. 3. Establish an initial detailed case formulation of limited scope and time frame. In his/her efforts to get to know and to understand the patient drug abuse/dependence problems, the counselor should learn about typical behavioral patterns in the current daily life of the patient. 4. Devise an initial treatment plan, which includes behavioral changes in the everyday life of the patient and develop explicit contracts, or agreements, that the patient will engage in specified activities outside the therapy sessions.

16 BDRC Treatment Manual for HPTN058 July 2010 page At each session, review contract completion and administer detailed, systematic, and positively framed feedback on goals achievement. Devise modified contracts when the patient fails to fully accomplish previously contracted activities. 6. Identify the patient s existing problems in other areas and provide a summary of these problem areas, as well as recommendations on how to deal with them in the subsequent treatment programs or concurrently utilizing resources available in the community. 7. Teach the patient to recognize physiological and emotional states, social and environmental factors, as well as various life problems associated with urges to use drugs. Help the patient to develop effective, problem solving strategies and to learn effective coping skills to maintain drug abstinence and avoid health risks from relapse to drug use or other risk behaviors. 8. Over time, after initiation of drug abstinence and initial lifestyle changes, develop with the patient an explicit detailed plan on how to continue making significant lifestyle changes and how to practice newly acquired coping and problem solving skills in real-life situations, using a small step approach. V. Sequence of BDRC sessions: A. Initial Phase: Education and short-term behavioral contracting All BDRC sessions are highly structured and follow a clear therapeutic approach based on general principles of cognitive behavioral treatments that is explicitly discussed/communicated between the counselor and the patient. The first session introduces the patient and counselor, provides an overview of the treatment approach that will be used and begins the process of developing a helpful, therapeutic relationship. The session provides an opportunity to evaluate the patient s immediate circumstances and problems related to drug use as well as the patient s potential strengths and areas of success. By the end of the first session, the counselor and patient should have developed an explicit contract regarding patient s participation in the next several counseling sessions and in all other treatment components (e.g., a contract in one of the following areas: a) timely attendance at medication dosing appointments, b) timely attendance at scheduled counseling sessions, or c) timely attendance at study related medical evaluation, or other evaluation visits with study personnel if applicable) as well as rules of conduct endorsed by the treatment facility. Subsequent sessions start with a friendly greeting followed by the review of the patient s progress in completing the contracts and in achieving or maintaining drug abstinence and other relevant behavioral goals. In general, the initial sessions of BDRC focus on education and behavioral changes targeting a limited number of specific, current patient problems. The major therapeutic tasks of the initial phase of treatment involve teaching the patient about the disease of opiate dependence and effective treatments of this condition and the development, evaluation, and revision of behavioral patient contracts. Contracts comprise the patient s intentional statements to engage in therapeutic activities outside of each counseling session. In session, the counselor reviews the patient s progress with contract item completion and administers positively framed feedback regarding contract completion. Successful completion of contract items demonstrates to patients that larger goals are achievable when they are broken down into smaller, concrete, goals and when realistic, well-defined steps are specified and systematically executed.

17 BDRC Treatment Manual for HPTN058 July 2010 page 17 Detailed discussion of the patient s efforts to complete the contract provides an opportunity to acknowledge the patient s efforts and successes, as well as to help the patient become increasingly aware of their active problem solving skills. During the contract review, the counselor breaks down the steps and skills that the patient used to implement any component or the entire contract and can thus acknowledge even partial success and provide positive feedback for successive approximation of behavioral change. During the session, the counselor also works with the patient to problem solve about any difficulties encountered completing the contract or the need to modify the contract. By the end of the session the counselor and patient should develop a new, short-term contract that the patient has a high likelihood of being able to complete successfully and that the patient commits to completing prior to the next session. As patients develop greater familiarity with the contracting procedure, the time spent in a session reviewing and developing contracts may decrease, and counselors will have more time and opportunity to provide additional education and specific individualized instructions regarding cognitive and behavioral relapse prevention and HIV risk reduction skills. While working on the short-term contracts in the initial phase of BDRC, the counselor and patient can also begin to identify longer-term treatment goals and to plan specific counseling interventions that can help the patient accomplish these goals. These longer-term goals and treatment plans are then articulated in a summary session with the patient that serves as the transition to longer-term treatment. The transition to the longer-term counseling interventions generally occurs after completion of the first four to six weeks of treatment. During the second phase of treatment, the counselor and patient continue to use behavioral contracts and to focus on the lifestyle changes initiated in the first phase of treatment. Note, however, that some topics included in the second phase of treatment (usually planned for sessions 7-22) may be introduced earlier in treatment, during the first 4-6 weeks, if they are thought to be critical for the patient to achieve abstinence. Note also that the sequence of sessions and topics planned for sessions 7-22 may be varied, depending on the needs of the patient. As counselors gain greater experience with BDRC, they are able to use the BDRC manual more flexibly to address at the most appropriate time the specific treatment needs of individual patients. Session 1 (study week 1): Introduction of the counselor; reasons for seeking treatment and patient s immediate goals or plans; education about the disease of opiate dependence and components of effective treatment; evaluation of the current patient status focusing on identification of typical behaviors and activities including identification of non-drug-related activities that the patient is capable of executing; overview of the treatment components, process, and the rules of conduct; initial therapeutic contract on treatment participation and compliance (e.g., timely attendance in medication dosing appointments or timely attendance in counseling sessions); Immediately after Session 1: Complete and/or organize the session notes, review new information obtained from the patient and select potential future contract(s) or contracting areas. Before each session: Check the patient's most recent urine results and review the session notes recalling the latest contract and the major themes or issues from the previous sessions. Review the Counselor s Handbook and familiarize with the topics that are appropriate to the patient's current phase in recovery. Prepare a detailed, step-by-step plan for the upcoming session.

18 BDRC Treatment Manual for HPTN058 July 2010 page 18 Session 2 (study week 2): Detailed review and positively framed feedback on treatment compliance (initial contract); brief review of current developments or changes in patient s life since the last session; continuing education about medical conceptualization of opiate dependence/addiction and treatment including the role of medications, counseling, and lifestyle changes; contracting for a small but significant behavioral change in patient s lifestyle. Immediately after each session: Complete and/or organize the session notes, review new information obtained from the patient, select and plan for potential future behavioral contract(s) and educational topics based on the individualized treatment plan for the patient. Sessions 3 5: Detailed review of contract accomplishments; positive feedback on all successful steps; review of problems and obstacles preventing the patient from accomplishing the contract, modification of the unsuccessful contract or its unsuccessful elements. Continuing education about medical conceptualization of opiate dependence as a brain disease and effective recovery strategies, as well as education on health risks of drug use and unsafe behaviors associated with drug use and sexual practices. Session 6 (summary feedback and evaluation - typically study week 6): Detailed review of the most recent contract; overall summary review of patient accomplishments and positive changes that happened during the initial sessions of BDRC; counselor s summary feedback/evaluation of patient s remaining problems and his/her recommendations regarding the longer-term treatment plans. The exact duration of the Phase 1 of BDRC is not fixed and cannot be predetermined for each patient entering BDRC treatment. Although typically it takes about 4 to 6 sessions for the initiation of significant behavioral changes and the achievement of significant periods of abstinence from illicit drugs, the rate of progress in BDRC can vary from one study participant to another. It is recommended that counselors implement BDRC in highly individualized fashion adjusting the rate of progression through counseling components prescribed in this manual depending on the unique characteristics and/or the rate of recovery progress of each individual study participant. The summary feedback and evaluation session outlined above plays an important role in the overall sequence of BDRC treatment. B. Phase 2: Continued Contracting, Relapse Prevention, Problem Solving, Coping Skills, Lifestyle Change, HIV Risk Reduction, and Sustained Recovery Sessions 7-22: During each of the remaining weekly or monthly BDRC sessions, the counselors should continue to develop, review, and modify new short-term, small-steps behavioral contracts. Continue to provide training in problem solving, relapse prevention, lifestyle change, as well as additional education on HIV risk reduction and skills to maintain a lifestyle supportive of sustained recovery. Phase 2 sessions follow the same format and utilize the same educational and therapeutic techniques/interventions as Phase 1 sessions. Counselors should continue to emphasize the positive aspects of recovery, provide positively framed feedback on all accomplishments, and help the patient to continue improving and reengaging in incomplete or failed contracting efforts.

19 BDRC Treatment Manual for HPTN058 July 2010 page 19 VII. Introduction to Counselor s Handbook Structure of Behavioral Drug and Risk Reduction Counseling (BDRRC) This counselor s handbook contains session-by-session recommendations for implementing Behavioral Drug and Risk Reduction Counseling (BDRC). The initial phase of BDRC comprises six 45 to 60- minute weekly sessions during the initial period of a drug treatment program. The second phase of BDRC comprises an additional 16 sessions (offered weekly or monthly) focusing on cognitive and behavioral skill building, relapse prevention, additional HIV risk reduction and health education, and other specific recovery-related topics individually selected for each patient. Manual Format Description of each session includes the overall session goals, recommended content areas, examples of contracts and communication scripts, as well, as session checklists. Please note that the examples of contracts and communication scripts included in this manual are only for illustration purposes. They are based on previous experiences with providing BDRC treatment to patients in different cultural and social settings and may not accurately reflect typical problems encountered by the HPTN058 study participants in Asia. BDRC counselors working in HPTN058 study are strongly encouraged to replace the current examples with examples and scripts based on their own, actual experiences in providing BDRC or other forms of psychosocial interventions. For the purpose of ease of reading, the counselor is designated as female and the patient is designated as male. Phase One of BDRC The first six sessions BDRC Session 1 The aims of the first session are to: 1) Introduce the counselor and provide overview of all study treatment components and rules of conduct 2) Review patient s current opiate and other drug use and related symptoms 3) Review patient s behavioral risks (i.e., HIV, HCV, STD and other infectious or bloodborne diseases risks) 4) Review patient s reasons for seeking treatment, immediate goals and plans 5) Discuss patient s current daily activities 6) Develop first contract In the first session, the counselor focuses on the development of a therapeutic alliance. She introduces herself as someone who is knowledgeable in substance abuse treatment, describes her role in treatment, explains the treatment components and their sequence to the patient, and describes expectations and rules of conduct during the entire treatment. Then she encourages the patient to introduce himself, to describe his current most significant problems with drug use, and the reasons for seeking treatment. The counselor provides a strong positive feedback of patient s recent efforts to become abstinent, as indicated by his treatment participation and/or other recent changes (e.g., reported efforts to cut down on drug use, changing from injecting to

20 BDRC Treatment Manual for HPTN058 July 2010 page 20 other routes of drug use) and expresses a strong conviction that working together on such efforts would result in even greater success in the future. A common finding in psychotherapy outcome research is that the working relationship between the counselor and patient (i.e., therapeutic alliance), especially early on in treatment, is a key vehicle for positive change. Counselor Introduction The counselor begins the session by briefly introducing herself. This introduction comprises a succinct summary of her counseling experience, experience with patients with opiate problems, and the improvements that these patients have made with BDRC. The aim of this introduction is to establish the counselor as a friendly, interested, helpful and non-judgmental person and to instill or augment hope in the patient that change is possible and that BDRC can help the patient succeed. Patient s Reasons for Seeking Treatment The counselor asks the patient to outline his current most significant problems associated with drug use and his reasons for seeking treatment. For example, What brings you in here today? Why did you choose to enroll in this study? If the counselor notices any reluctance or ambivalence on the part of the patient, she addresses this in an open, nonjudgmental manner. For example, What would you like to talk about today? What would you like me to know about you? In addition to providing information about the patient s current situation and his motivation to engage in treatment, explicating the reasons for seeking treatment may inform the content of initial contracts. For example, if the patient tells the counselor that he is required to enter treatment because of legal problems, the counselor can prescribe a short-term drug abstinence contract goal, which is framed as a way of helping the patient meet externally imposed requirements. Counselor Feedback The counselor provides the patient with positive feedback regarding his decision to enter treatment. She offers positive feedback for any possible patient achievements (e.g., recent reduction in opiate use, patient s decision to seek treatment) and emphasizes that they represent very important steps toward sustained abstinence. For example, So you decided to enter treatment because your wife threatened to leave you if you didn t become clean. Your choice to follow up on your wife s comments is an important one. You could have chosen to ignore her but you did not. It is important that we also acknowledge that you have managed to decrease your use. You were using 2 bundles a day and you managed to cut down to 1 bundle a day. Making the decision to enter a treatment program and cutting down on your heroin use are important first steps on the road to achieving abstinence. In addition to providing positively framed feedback based on the patient s performance or efforts and detailing the positive consequences of the patient s actions, the counselor assesses the patient s concomitant emotional experiences. For example, How do you feel about the positive changes you have made so far?