Behavioral Activation for Heroin Use in China: A Randomized Controlled Trial
NCT ID: NCT03705143
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2018-06-04
2018-12-05
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment as Usual
Participants will receive no additional intervention besides the services they are currently receiving at the MMT clinic.
Treatment as usual
Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.
Chinese translated LETS ACT
In addition to services participants are currently receiving at the MMT clinic, individuals will attend six group-based one-hour behavioral activation treatment sessions.
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.
Interventions
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Treatment as usual
Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Psychosis
* PTSD
* The inability to give informed, voluntary, written consent to participate
18 Years
65 Years
ALL
No
Sponsors
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Wuhan Center for Disease Control and Prevention
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Stacey Daughters, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Wuhan Center for Disease Control and Prevention
Wuhan, Hubei, China
Countries
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References
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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.
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.
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.
Chawarski MC, Zhou W, Schottenfeld RS. Behavioral drug and HIV risk reduction counseling (BDRC) in MMT programs in Wuhan, China: a pilot randomized clinical trial. Drug Alcohol Depend. 2011 Jun 1;115(3):237-9. doi: 10.1016/j.drugalcdep.2010.09.024. Epub 2010 Dec 14.
Wang L, Wang N, Wang L, Li D, Jia M, Gao X, Qu S, Qin Q, Wang Y, Smith K. The 2007 Estimates for People at Risk for and Living With HIV in China: Progress and Challenges. J Acquir Immune Defic Syndr. 2009 Apr 1;50(4):414-8. doi: 10.1097/QAI.0b013e3181958530.
Yin L, Qin G, Ruan Y, Qian HZ, Hao C, Xie L, Chen K, Zhang Y, Xia Y, Wu J, Lai S, Shao Y. Nonfatal overdose among heroin users in southwestern China. Am J Drug Alcohol Abuse. 2007;33(4):505-16. doi: 10.1080/00952990701407223.
Zhang L, Chow EP, Zhuang X, Liang Y, Wang Y, Tang C, Ling L, Tucker JD, Wilson DP. Methadone maintenance treatment participant retention and behavioural effectiveness in China: a systematic review and meta-analysis. PLoS One. 2013 Jul 26;8(7):e68906. doi: 10.1371/journal.pone.0068906. Print 2013.
Feng Y, Wu Z, Detels R, Qin G, Liu L, Wang X, Wang J, Zhang L. HIV/STD prevalence among men who have sex with men in Chengdu, China and associated risk factors for HIV infection. J Acquir Immune Defic Syndr. 2010 Feb;53 Suppl 1(Suppl 1):S74-80. doi: 10.1097/QAI.0b013e3181c7dd16.
Sun HM, Li XY, Chow EP, Li T, Xian Y, Lu YH, Tian T, Zhuang X, Zhang L. Methadone maintenance treatment programme reduces criminal activity and improves social well-being of drug users in China: a systematic review and meta-analysis. BMJ Open. 2015 Jan 8;5(1):e005997. doi: 10.1136/bmjopen-2014-005997.
Marienfeld C, Liu P, Wang X, Schottenfeld R, Zhou W, Chawarski MC. Evaluation of an implementation of methadone maintenance treatment in China. Drug Alcohol Depend. 2015 Dec 1;157:60-7. doi: 10.1016/j.drugalcdep.2015.10.001. Epub 2015 Oct 8.
Lu L, Fang Y, Wang X. Drug abuse in China: past, present and future. Cell Mol Neurobiol. 2008 Jun;28(4):479-90. doi: 10.1007/s10571-007-9225-2. Epub 2007 Nov 8.
Other Identifiers
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18-0885
Identifier Type: -
Identifier Source: org_study_id
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