Clinical trial NCT03705143: Behavioral Activation for Heroin Use in China: A Randomized Controlled Trial
Official title: The Behavioral Activation for Chinese Substance Users (C-BA) Research Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Mood Disorders
Behavioral Activation Treatment
Mental Disorders
Keywords: Disease
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Substance use Disorders
Chinese heroin user
Culture
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Wuhan Center for Disease Control and Prevention
First posted: 2018-10-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the % substance use days over time
timeFrame: Pretreatment through 3-month post treatment discontinuation
Secondary outcomes:
measure: Change in # of participants showing positive urinalysis results over the course of the study
timeFrame: Pretreatment through 3-month post treatment discontinuation
measure: Change in Beck Depression Inventory-II (BDI-II) Score over the course of the study
timeFrame: Pretreatment through 3-month post treatment discontinuation
measure: Change in Behavioral Activation for Depression Scale (BADS) Scores over the course of the study
timeFrame: Pretreatment through 3-month post treatment discontinuation
measure: Change in Reward Probability Index (RPI) Scores over the course of the study
timeFrame: Pretreatment through 3-month post treatment discontinuation
measure: Change in % days participants take methadone at the clinic over the course of the study
timeFrame: Pretreatment through 3-month post treatment discontinuation
measure: Change in % days participants engaged in Daily Goals Form over the course of the study
timeFrame: Pretreatment through 3-month post treatment discontinuation
measure: Feasibility of the treatment
timeFrame: Three weeks since pre-treatment assessment
measure: Acceptability o the treatment
timeFrame: Three weeks since pre-treatment assessment
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Center for Disease Control and Prevention
state: Hubei
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stacey Daughters, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daughters SB, Braun AR, Sargeant MN, Reynolds EK, Hopko DR, Blanco C, Lejuez CW. Effectiveness of a brief behavioral treatment for inner-city illicit drug users with elevated depressive symptoms: the life enhancement treatment for substance use (LETS Act!). J Clin Psychiatry. 2008 Jan;69(1):122-9. doi: 10.4088/jcp.v69n0116.
citation: Daughters SB, Magidson JF, Anand D, Seitz-Brown CJ, Chen Y, Baker S. The effect of a behavioral activation treatment for substance use on post-treatment abstinence: a randomized controlled trial. Addiction. 2018 Mar;113(3):535-544. doi: 10.1111/add.14049. Epub 2017 Nov 19.
citation: Daughters, S. B., Magidson, J. F., Lejuez, C. W., & Chen, Y. (2016). LETS ACT: a behavioral activation treatment for substance use and depression. Advances in Dual Diagnosis, 9(2/3), 74-84.
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