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

NCT03705143 | Completed

• 1 other identifier: 18-0885
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in # of participants showing positive urinalysis results over the course of the study

  Pretreatment through 3-month post treatment discontinuation

• Change in Beck Depression Inventory-II (BDI-II) Score over the course of the study

  Pretreatment through 3-month post treatment discontinuation

• Change in Behavioral Activation for Depression Scale (BADS) Scores over the course of the study

  Pretreatment through 3-month post treatment discontinuation

• Change in Reward Probability Index (RPI) Scores over the course of the study

  Pretreatment through 3-month post treatment discontinuation

• Change in % days participants take methadone at the clinic over the course of the study

  Pretreatment through 3-month post treatment discontinuation

Study Arms (2)

Treatment as Usual

PLACEBO COMPARATOR

Participants will receive no additional intervention besides the services they are currently receiving at the MMT clinic.

Behavioral: Treatment as usual

Chinese translated LETS ACT

EXPERIMENTAL

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

Interventions

Treatment as usual BEHAVIORAL

Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.

Also known as: TAU

Treatment as Usual

Chinese translated LETS ACT BEHAVIORAL

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.

Also known as: Chinese translated Behavioral Activation

Chinese translated LETS ACT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Reading level below 5th grade
• Psychosis
• PTSD
• The inability to give informed, voluntary, written consent to participate

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Wuhan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Wuhan Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

Related Publications (11)

• 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.

  PMID: 18312046 BACKGROUND

• 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.

  PMID: 28963853 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21159452 BACKGROUND

• 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.

  PMID: 19214116 BACKGROUND

• 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.

  PMID: 17668336 BACKGROUND

• 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.

  PMID: 23922668 BACKGROUND

• 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.

  PMID: 20104114 BACKGROUND

• 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.

  PMID: 25573521 BACKGROUND

• 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.

  PMID: 26601934 BACKGROUND

• 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.

  PMID: 17990098 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Mood Disorders; Mental Disorders; Disease; Depressive Disorder; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Stacey Daughters, Ph.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 15, 2018
• Study Start: June 4, 2018
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)