Behavioral Activation for Heroin Use in China: A Randomized Controlled Trial

Study Overview
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Brief Summary
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This was a single-site two-arm parallel-group trial conducted in a Methadone Maintenance Treatment (MMT) Clinic that provides medication service for 254 heroin users in Wuhan, China. Once consented and completed the pre-treatment assessment, participants were randomized to receive either the Chinese translated behavioral activation treatment for substance use (C-BA) or treatment as usual (TAU). Research assessments occurred at pre-treatment, post-treatment, and 1- and 3-months follow-ups. The primary purpose of this study is to: 1. Evaluate the feasibility, acceptability, and efficacy of the Chinese-translated behavioral activation treatment for substance use (C-BA), an evidence based intervention developed to address the individual and psychological needs of Chinese substance users. The secondary purpose of this study is to: Examine the underlying mechanism of C-BA by studying the relationship between change in substance use related outcomes and associated psychological constructs (e.g. levels of behavioral activation and depression).

Detailed Description
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Over 83% registered drug users in China are primary heroin users. Heroin use is associated with numerous severe health consequences, including elevated risk for HIV, STDs, and fatal overdose. Methadone maintenance treatment (MMT) has become the standard treatment approach for heroin use that show effectiveness in reducing drug injection, HIV transmission, and criminal activities associated with heroin use in China. Nevertheless, dropout rates among MMT seekers is high in China (50%-70% drop out rate three months post treatment initiation), and research suggests that it is important to provide psychosocial treatments for substance use along with MMT. The combined treatment may both increase treatment adherence and result in superior substance use treatment outcomes. The Chinese-translated behavioral activation treatment (C-BA) for substance use was translated from the Life Enhancement Treatment for Substance Use (LETS ACT), an evidence based treatment for substance use in the United States. C-BA may fit the need in China because it is a cost-effective and low training-burden treatment designed to be implemented under settings with limited resources. Similar to LETS ACT, C-BA aims to improve substance use outcomes by helping the individuals engage in drug-free value based activities. Recent studies reported that compared to participants in the supportive counseling group, individuals who received LETS ACT shows significantly higher abstinence rates at 3 months [odds ratio (OR) = 2.2, 95% confidence interval (CI) = 1.3-3.7], 6 months (OR = 2.6, 95% CI= 1.3-5.0) and 12 months (OR = 2.9, 95% CI = 1.3-6.1) post-treatment. Additionally, LETS ACT participants reported significantly fewer adverse consequences from substance use at 12 months post-treatment [B = 4.50, standard error (SE) = 2.17, 95% CI = 0.22-8.78]. In another pilot study, the feasibility and acceptability of C-BA was evaluated among six Chinese international students in the United States. Results suggest that C-BA is associated with both statistical and clinical improvement in depressive symptoms and access to environmental rewards up until 1 month post treatment. The study has a 100% research and treatment retention rate, high homework completion rate (> 80% completion rate), and all participants reported that C-BA is highly culturally acceptable. These preliminary evidence support the feasibility of implementing C-BA among Chinese substance users. Taken together, research suggests that C-BA could be a feasible treatment that has the potential to reduce substance use, alleviate depressive symptoms, and improve levels of behavioral activation among Chinese heroin users. To date, no study has investigated the feasibility, acceptability and efficacy of C-BA among Chinese heroin users seeking MMT treatment. The present study aims to address this need by conducting a randomized controlled trial to examine the acceptability, feasibility, and efficacy of C-BA among 90 Chinese heroin users seeking MMT. In the current study, the investigators will examine the treatment specifically with regard to major depression, reinforcement, adherence to MMT, and abstinence from substance use. The investigators will also examine the underlying mechanism of C-BA by studying the relationship between change in substance use related outcomes and associated psychological constructs (e.g. levels of behavioral activation and depression).

Official Title
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The Behavioral Activation for Chinese Substance Users (C-BA) Research Protocol

Conditions
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Substance-Related Disorders, Mood Disorders, Behavioral Activation Treatment, Mental Disorders

Intervention / Treatment
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* Behavioral: Treatment as usual
* Behavioral: Chinese translated LETS ACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently receiving Methadone Maintenance Treatment Between 18 and 65 No outstanding health conditions Has received MMT treatment for more than three weeks Will continue MMT treatment for at least four more weeks Exclusion Criteria: Reading level below 5th grade Psychosis PTSD The inability to give informed, voluntary, written consent to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Treatment as Usual<br>Participants will receive no additional intervention besides the services they are currently receiving at the MMT clinic. | Behavioral: Treatment as usual<br>* Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.<br>* Other names: TAU;|
| Experimental: Chinese translated LETS ACT<br>In addition to services participants are currently receiving at the MMT clinic, individuals will attend six group-based one-hour behavioral activation treatment sessions. | Behavioral: Chinese translated LETS ACT<br>* The Chinese translated Behavioral Activation (C-BA) will be provided in Mandarin. C-BA treatment includes psychoeducation regarding the link between mood and behavior, identification of values/goals/activities across life areas, planning and tracking of daily value driven activities.<br>* Other names: Chinese translated Behavioral Activation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the % substance use days over time | The frequency of substance use over the past 30 days was measured by a Timeline Followback Interview (TLFB).The % was calculated by using the # of days participants used substance during the 30-day period prior to each assessment point divided by 30. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation. The exception is the post-treatment assessment which will only includes a 21 day period. The TLFB is a questionnaire in which the subject is asked to self-report types and frequency of substance use for the past 30 days. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in % of days using substance over the course of the study. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in % of days using substance that is clinically significant. | Pretreatment through 3-month post treatment discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in # of participants showing positive urinalysis results over the course of the study | Urinalysis is a biological measure of substance use. Statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in # of participants showing positive urinalysis results over time. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation. | Pretreatment through 3-month post treatment discontinuation | 
| Change in Beck Depression Inventory-II (BDI-II) Score over the course of the study | The BDI-II is a 21-item self-report measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in BDI-II total scores over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in BDI-II total scores that are clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation. | Pretreatment through 3-month post treatment discontinuation | 
| Change in Behavioral Activation for Depression Scale (BADS) Scores over the course of the study | The BADS is a 25-item self-report measure of overall level of activity involvement. Scores range from 25 - 175, with higher scores indicating greater levels of activity involvement. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in BADS total scores over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in BADS total scores that is clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation. | Pretreatment through 3-month post treatment discontinuation | 
| Change in Reward Probability Index (RPI) Scores over the course of the study | The RPI is a 20-item self-report measure used to assess environmental reward and punishment. Scores range from 0 - 60, with higher scores indicating greater levels of access to environmental rewards. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in RPI total scores over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in RPI total scores that is clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation. | Pretreatment through 3-month post treatment discontinuation | 
| Change in % days participants take methadone at the clinic over the course of the study | Methadone treatment adherence is measured by participant's % of days visiting MMT clinic during the course of the study. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in % days participants take methadone at the clinic over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in % days participants take methadone at the clinic that is clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation. | Pretreatment through 3-month post treatment discontinuation | 
| Change in % days participants engaged in Daily Goals Form over the course of the study | The Daily Goals Form is used to measure Treatment Engagement. The % days participants engaged in Daily goals Form was calculated by dividing the total # of days participants completed the Daily Goals Form by the total # of days they were given the opportunity to complete the Daily Goals Form. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation. Once the % is calculated, on the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in % days participants engaged in Daily Goals Form over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in % days participants engaged in Daily Goals Form that is clinically significant. | Pretreatment through 3-month post treatment discontinuation | 
| Feasibility of the treatment | Feasibility of the treatment was measured by the following outcomes: % of participated treatment sessions and scores of the Working Alliance Inventory (WAI). WAI is a 12-item self-report measure of the quality of therapist-client alliance. Scores range from 12 to 48, with higher scores indicating stronger working alliance. | Three weeks since pre-treatment assessment | 
| Acceptability o the treatment | Acceptability of the treatment was measured scores of the Treatment Acceptability Questionnaire (TAQ). Treatment Acceptability Questionnaire (TAQ) is a 6-item self-report measure of patient's rating of the treatment's acceptability, ethics, effectiveness, negative side effects, therapist knowledge, and therapist trustworthiness. Score range between 6 and 42, with higher scores indicate greater treatment acceptability. | Three weeks since pre-treatment assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese heroin user, Culture, Disease, Depressive Disorder, Depression, Mood Disorders, Mental Disorders, Substance use Disorders