Behavioral Activation for Heroin Use in China: A Randomized Controlled Trial
Condition: Substance-Related Disorders; Mood Disorders; Behavioral Activation Treatment; Mental Disorders
MeSH terms: Substance-Related Disorders; Mental Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional

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).
    

Intervention name(s): Treatment as usual; Chinese translated LETS ACT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.; 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.
Other intervention name(s): TAU; Chinese translated Behavioral Activation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Disease; Depressive Disorder; Depression; Mood Disorders; Mental Disorders; Substance use Disorders; Chinese heroin user; Culture