NCT03705143

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Substance-Related Disorders
• Mood Disorders
• Behavioral Activation Treatment
• Mental Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Treatment as usual	Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.
BEHAVIORAL	Chinese translated LETS ACT	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.

Timeline

• Start date: 2018-06-04
• Primary completion: 2018-12-05
• Completion: 2018-12-05
• First posted: 2018-10-15
• Last updated: 2019-02-01

Locations

1 site across 1 country: China