Substance-Related DisordersNCT03705143
Behavioral Activation for Heroin Use in China: A Randomized Controlled Trial
A study testing Treatment as usual and Chinese translated LETS ACT in people with Substance-Related Disorders and Mood Disorders, run by University of North Carolina, Chapel Hill at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance-Related Disorders, Mood Disorders, Behavioral Activation Treatment
- What is being tested?
- Treatment as usual and Chinese translated LETS ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2018to 5 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Reading level below 5th grade
- Psychosis
- PTSD
- The inability to give informed, voluntary, written consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Behavioral Activation for Chinese Substance Users (C-BA) Research Protocol
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:
Read more
- 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).
Read the 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
- Being tested
- Treatment as usual, Chinese translated LETS ACT
- Keywords
- Disease, Depressive Disorder, Depression, Mood Disorders, Mental Disorders, Substance use Disorders, Chinese heroin user, Culture
- Medical subject headings
- Substance-Related Disorders, Mood Disorders, Mental Disorders, Disease, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
Also called TAU
Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.
Chinese translated LETS ACTBehavioural
Also called Chinese translated Behavioral Activation
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Placebo comparator | Participants will receive no additional intervention besides the services they are currently receiving at the MMT clinic. Receives: 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. Receives: Behavioral: Chinese translated LETS ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pretreatment through 3-month post treatment discontinuation
Secondary outcomes (8)
Change in # of participants showing positive urinalysis results over the course of the study
Urinalysis is a biological measure of substance use. Statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in # of participants showing positive urinalysis results over time. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation.
Measured: Pretreatment through 3-month post treatment discontinuation
Change in Beck Depression Inventory-II (BDI-II) Score over the course of the study
The BDI-II is a 21-item self-report measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in BDI-II total scores over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in BDI-II total scores that are clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation.
Measured: Pretreatment through 3-month post treatment discontinuation
Change in Behavioral Activation for Depression Scale (BADS) Scores over the course of the study
The BADS is a 25-item self-report measure of overall level of activity involvement. Scores range from 25 - 175, with higher scores indicating greater levels of activity involvement. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in BADS total scores over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in BADS total scores that is clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation.
Measured: Pretreatment through 3-month post treatment discontinuation
Change in Reward Probability Index (RPI) Scores over the course of the study
The RPI is a 20-item self-report measure used to assess environmental reward and punishment. Scores range from 0 - 60, with higher scores indicating greater levels of access to environmental rewards. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in RPI total scores over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in RPI total scores that is clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation.
Measured: Pretreatment through 3-month post treatment discontinuation
Change in % days participants take methadone at the clinic over the course of the study
Methadone treatment adherence is measured by participant's % of days visiting MMT clinic during the course of the study. On the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in % days participants take methadone at the clinic over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in % days participants take methadone at the clinic that is clinically significant. Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation.
Measured: Pretreatment through 3-month post treatment discontinuation
Change in % days participants engaged in Daily Goals Form over the course of the study
The Daily Goals Form is used to measure Treatment Engagement. The % days participants engaged in Daily goals Form was calculated by dividing the total # of days participants completed the "Daily Goals Form" by the total # of days they were given the opportunity to complete the "Daily Goals Form." Data was collected at pre-treatment, post-treatment, 1-month post treatment discontinuation and 3-month post treatment discontinuation.
Once the % is calculated, on the group level, statistical methods such as multi-level modeling (MLM) will be used to assess group differences in change in % days participants engaged in Daily Goals Form over time. On the individual level, statistical methods such as Reliable Change Index (RCI) will be used to assess change in % days participants engaged in Daily Goals Form that is clinically significant.
Measured: Pretreatment through 3-month post treatment discontinuation
Feasibility of the treatment
Feasibility of the treatment was measured by the following outcomes: % of participated treatment sessions and scores of the Working Alliance Inventory (WAI).
WAI is a 12-item self-report measure of the quality of therapist-client alliance. Scores range from 12 to 48, with higher scores indicating stronger working alliance.
Measured: Three weeks since pre-treatment assessment
Acceptability o the treatment
Acceptability of the treatment was measured scores of the Treatment Acceptability Questionnaire (TAQ).
Treatment Acceptability Questionnaire (TAQ) is a 6-item self-report measure of patient's rating of the treatment's acceptability, ethics, effectiveness, negative side effects, therapist knowledge, and therapist trustworthiness. Score range between 6 and 42, with higher scores indicate greater treatment acceptability.
Measured: Three weeks since pre-treatment assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start4 Jun 2018
- Primary completion5 Dec 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Stacey Daughters, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705143
- Sponsor's protocol ID
- 18-0885
- Status last verified
- Jan 2019
- First submitted
- 2 Oct 2018
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18312046Daughters 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.
PubMed 28963853Daughters, 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.
PubMed 21159452Wang 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.
PubMed 19214116Yin 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.
PubMed 17668336Zhang 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.
PubMed 23922668Feng 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.
PubMed 20104114Sun 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.
PubMed 25573521Marienfeld 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.
PubMed 26601934Lu 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.
PubMed 17990098
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Behavioral Activation for Chinese Substance Users (C-BA) Research Protocol
- ClinicalTrials.gov ID
- NCT03705143
- Acronym / sponsor ID
- 18-0885
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Wuhan Center for Disease Control and Prevention
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Placebo comparator | Behavioral: Treatment as usualParticipants will receive no additional intervention besides the services they are currently receiving at the MMT clinic. |
| Chinese translated LETS ACT | Experimental | Behavioral: Chinese translated LETS ACTIn addition to services participants are currently receiving at the MMT clinic, individuals will attend six group-based one-hour behavioral activation treatment sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Reading level below 5th grade
- Psychosis
- PTSD
- The inability to give informed, voluntary, written consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualAlso: TAUTreatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China. | Behavioural | Treatment as Usual |
| Chinese translated LETS ACTAlso: Chinese translated Behavioral ActivationThe 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. | Behavioural | Chinese translated LETS ACT |
Primary outcome
Change in the % substance use days over time
Time frame: Pretreatment through 3-month post treatment discontinuation
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.
8 secondary outcomes
Change in # of participants showing positive urinalysis results over the course of the study
Time frame: Pretreatment through 3-month post treatment discontinuation
Change in Beck Depression Inventory-II (BDI-II) Score over the course of the study
Time frame: Pretreatment through 3-month post treatment discontinuation
Change in Behavioral Activation for Depression Scale (BADS) Scores over the course of the study
Time frame: Pretreatment through 3-month post treatment discontinuation
Change in Reward Probability Index (RPI) Scores over the course of the study
Time frame: Pretreatment through 3-month post treatment discontinuation
Change in % days participants take methadone at the clinic over the course of the study
Time frame: Pretreatment through 3-month post treatment discontinuation
Change in % days participants engaged in Daily Goals Form over the course of the study
Time frame: Pretreatment through 3-month post treatment discontinuation
Feasibility of the treatment
Time frame: Three weeks since pre-treatment assessment
Acceptability o the treatment
Time frame: Three weeks since pre-treatment assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Background: PubMed 18312046Daughters 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.
- Background: PubMed 28963853Daughters 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.
- BackgroundDaughters, 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: PubMed 21159452Chawarski 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.
- Background: PubMed 19214116Wang 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.
- Background: PubMed 17668336Yin 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.
- Background: PubMed 23922668Zhang 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.
- Background: PubMed 20104114Feng 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.
- Background: PubMed 25573521Sun 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.
- Background: PubMed 26601934Marienfeld 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.
- Background: PubMed 17990098Lu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Daughters, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual and Chinese translated LETS ACT in people with Substance-Related Disorders and Mood Disorders, run by University of North Carolina, Chapel Hill at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the % substance use days over time (time frame: Pretreatment through 3-month post treatment discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705143, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.