An interventional study of Mindfulness Based Relapse Prevention and Standard of Care in Relapse/Recurrence, Substance Use (Drugs, Alcohol) and Burnout, sponsored by University of Texas at Austin. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Prevention
Adapt and test the effectiveness of MBRP for substance use peer workers compared to a standard of care (referral to 12-step) control condition on substance use, relapse risk, and burnout among peers in a pilot hybrid type 1 trial.
The goal of this clinical trial is to learn if Mindfulness-Based Relapse Prevention can reduce substance use, relapse risk, and burnout among substance use peer workers. The objectives are to:
Researchers will compare MBRP to referral to 12-step (standard of care) to see if MRBP works to reduce substance use, relapse risk, and burnout.
Participants will asked to:
University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MBRP for Peer Workers
Behavioral: Mindfulness Based Relapse Prevention
Standard of Care
Behavioral: Standard of Care
MBRP for peer workers consists of 8 weekly 2-hour virtual sessions.
Referral to 12-step programming
Change from baseline in biologically verified substance use at 1, 3, and 6 months as measured by Saliva Drug Assays
Saliva drug assays detecting the presence or absence of commonly used substances. Results are reported as positive or negative for each substance tested, with negative results indicating a better outcome.
Time frame: From enrollment to 6 months
Change from baseline in self-reported substance use days at 1, 3, and 6 months as measured by the Timeline Follow-Back (TLFB)
A calendar-based interview assessing daily substance use over a specified recall period. Outcomes are reported as the number of days of substance use during the assessment period, with fewer days indicating a better outcome.
Time frame: From enrollment to 6 months
Change from baseline in relapse warning Signs at 1, 3, and 6 months as measured by the Advance Warning of Relapse (AWARE) Questionnaire
A 28-item; 7-point Likert-type scale assessing warning signs associated with relapse risk. Total scores range from 28 to 196, with higher scores indicating greater relapse risk (worse outcome).
Time frame: From enrollment to 6 months
Change from baseline in professional quality of life at 1, 3, and 6 months as measured by the Professional Quality of Life Scale (ProQOL)
A 30-item; 5-point Likert-type scale assessing professional quality of life across three 10-item subscales: Compassion Satisfaction, Burnout, and Secondary Traumatic Stress. Each subscale score ranges from 10 to 50. Higher Compassion Satisfaction scores indicate a better outcome, whereas higher Burnout and Secondary Traumatic Stress scores indicate worse outcomes.
Time frame: From enrollment to 6 months
Post-intervention perceived feasibility of the intervention as measured by the Feasibility of Intervention Measure (FIM)
A 4-item; 5-point Likert-type scale assessing the perceived feasibility of an intervention. Total scores range from 4 to 20, with higher scores indicating greater perceived feasibility (better outcome).
Time frame: Immediately after the final intervention session
Post-intervention perceived acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
A 4-item; 5-point Likert-type scale assessing the perceived acceptability of an intervention. Total scores range from 4 to 20, with higher scores indicating greater perceived acceptability (better outcome).
Time frame: Immediately after the final intervention session
Change from baseline in the coping score assessed by the Brief-COPE measure at 6 months
A 28-item; 4-point Likert-type scale assessing coping strategies. The Brief COPE consists of 14 two-item subscales, each ranging from 2 to 8, with higher scores indicating greater use of that specific coping strategy. There is no overall total score.
Time frame: From enrollment to 6 months
Change from baseline in total score of emotion regulation assessed by the Difficulty in Emotion Regulation Scale (DERS) measure at 6 months
A 36-item; 5-point Likert-type scale assessing difficulties with emotion regulation. Total scores range from 36 to 180, with higher scores indicating greater difficulties in emotion regulation (worse outcome).
Time frame: From enrollment to 6 months
Change from baseline in total score of perceived stress assessed by the Perceived Stress Scale (PSS-10) measure at 6 months
A 10-item; 5-point Likert-type scale assessing perceived stress. Total scores range from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).
Time frame: From enrollment to 6 months
Change from baseline in total score of trait mindfulness assessed by the Five Factor Mindfulness Questionnaire (FFMQ-15) measure at 6 months
A 15-item; 5-point Likert-type scale assessing trait mindfulness. Total scores range from 15 to 75, with higher scores indicating greater mindfulness (better outcome).
Time frame: From enrollment to 6 months
Change from baseline in total score of acceptance assessed by the Acceptance and Action Questionnaire-II (AAQ-II) measure at 6 months
A 7-item; 7-point Likert-type scale assessing psychological inflexibility/experiential avoidance. Total scores range from 7 to 49, with higher scores indicating greater psychological inflexibility and experiential avoidance (worse outcome).
Time frame: From enrollment to 6 months
Change from baseline in mean score of mental health assessed by the Behavior and Symptom Identification Scale (BASIS-24) measure at 6 months
A 24-item; 5-point Likert-type scale assessing mental health symptoms and functioning. Total scores range from 0 to 4 (calculated as the mean of completed items), with higher scores indicating greater psychiatric symptoms and functional difficulties (worse outcome).
Time frame: From enrollment to 6 months
Change from baseline in mean score of recovery capital assessed by the Multidimensional Inventory of Recovery Capital (MIRC) measure at 6 months
A 28-item; 4-point Likert-type scale assessing recovery capital across multiple domains. Total scores range from 28 to 112, with higher scores indicating greater recovery capital (better outcome).
Time frame: From enrollment to 6 months
Change from baseline in mean score of work engagement assessed by the Utrecht Work Engagement Scale (UWES-9) measure at 6 months
A 9-item; 7-point Likert-type scale assessing work engagement. Total scores range from 0 to 54 (or a mean score ranging from 0 to 6), with higher scores indicating greater work engagement (better outcome).
Time frame: From enrollment to 6 months
Plan to share: Yes — De-identified individual participant data from quantitative assessments will be shared, including participant characteristics, intervention measures, primary outcomes, exploratory outcomes, and implementation outcomes collected at baseline and follow-up assessments (1, 3, and 6 months). Direct identifiers will not be shared. Qualitative interview data will not be shared due to the risk of participant re-identification. Supporting documentation, including codebooks, data dictionaries, and study-level metadata, will be provided to facilitate data reuse.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: IPD and supporting information will be available no later than publication of the primary study outcomes. Data will remain available indefinitely through the NIDA Data Share repository, with no anticipated end date.
Access criteria: De-identified IPD and supporting information will be available to qualified researchers through the NIDA Data Share repository. Researchers will be able to access de-identified quantitative participant-level data, associated metadata, study documentation, and data dictionaries/codebooks to support appropriate secondary analyses. Access will be provided through the standard NIDA Data Share request and review processes. Direct identifiers and qualitative interview data will not be made available.
Start is estimated for Aug 2026; primary completion for Jul 2030, 47 months later.
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