Relapse/RecurrenceMBRPNCT07741825
Mindfulness-based Relapse Prevention for Peer Workers
A study testing Mindfulness Based Relapse Prevention in people with Relapse/Recurrence and Substance Use (Drugs, Alcohol), run by University of Texas at Austin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Relapse/Recurrence, Substance Use (Drugs, Alcohol), Burnout
- What is being tested?
- Mindfulness Based Relapse Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are > 18 years old
- Fluent in English
- Be currently employed in a substance use peer support role
- At-risk for SUD relapse as measured by a craving score of >15 on the adapted Penn Alcohol Craving Scale
Who cannot join
- Have a cognitive impairment that jeopardizes informed consent
- Actively suicidal or psychotic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Addiction Research Institute
Austin, Texas, 78712
Katie A McCormick, PhD, MSW, (512) 471-5457, katie.mccormick@austin.utexas.edu
About this study
Official title: Adapting and Pilot Testing Mindfulness-Based Relapse Prevention for Substance Use Peer Workers
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:
Read more
- Identify the causes, consequences, and risk and protective factors for relapse among peer workers;
- Identify peers' preferences related to MBRP content, structure, and delivery;
- Adapt the MBRP intervention for peer workers; and
- Assess the preliminary effectiveness and implementation outcomes of the adapted MBRP intervention.
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:
- Participate in MBRP (8 weekly 2-hour virtual sessions)
- Complete 4 surveys assessing well-being outcomes
- Participate in 1 virtual interview about your experience
- Conditions
- Relapse/Recurrence, Substance Use (Drugs, Alcohol), Burnout
- Being tested
- Mindfulness Based Relapse Prevention, Standard of Care
- Keywords
- Mindfulness Based Relapse Prevention, Peer Recovery Specialist, Peer Worker, Coping Skills, Relapse, Recovery, Recovery Capital, Occupational Stress, Mindfulness
- Medical subject headings
- Recurrence, Substance-Related Disorders, Burnout, Psychological, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Relapse PreventionBehavioural
MBRP for peer workers consists of 8 weekly 2-hour virtual sessions.
Standard of CareBehavioural
Referral to 12-step programming
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | MBRP for Peer Workers Receives: Behavioral: Mindfulness Based Relapse Prevention |
| Control Arm | Active comparator | Standard of Care Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Immediately after the final intervention session
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapse/RecurrenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type 1 effectiveness-implementation pilot trial of MBRP adapted for substance use peer workers compared to a standard of care (referral to 12-step) control condition
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie McCormick, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741825
- Sponsor's protocol ID
- STUDY00009002
- Other IDs
- 1K01DA065810-01
- Acronym
- MBRP
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Witkiewitz K, Bowen S, Harrop EN, Douglas H, Enkema M, Sedgwick C. Mindfulness-based treatment to prevent addictive behavior relapse: theoretical models and hypothesized mechanisms of change. Subst Use Misuse. 2014 Apr;49(5):513-24. doi: 10.3109/10826084.2014.891845.
PubMed 24611847Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, Carroll HA, Harrop E, Collins SE, Lustyk MK, Larimer ME. Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):547-56. doi: 10.1001/jamapsychiatry.2013.4546.
PubMed 24647726Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.
PubMed 19904665Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.
PubMed 28727663
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Pilot Testing Mindfulness-Based Relapse Prevention for Substance Use Peer Workers
- ClinicalTrials.gov ID
- NCT07741825
- Acronym / sponsor ID
- MBRP / STUDY00009002
- Conditions
- Relapse/Recurrence, Substance Use (Drugs, Alcohol), Burnout
- Keywords
- Mindfulness Based Relapse Prevention, Peer Recovery Specialist, Peer Worker, Coping Skills, Relapse, Recovery, Recovery Capital, Occupational Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 3 Aug 2026 (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.
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:
- Identify the causes, consequences, and risk and protective factors for relapse among peer workers;
- Identify peers' preferences related to MBRP content, structure, and delivery;
- Adapt the MBRP intervention for peer workers; and
- Assess the preliminary effectiveness and implementation outcomes of the adapted MBRP intervention.
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:
- Participate in MBRP (8 weekly 2-hour virtual sessions)
- Complete 4 surveys assessing well-being outcomes
- Participate in 1 virtual interview about your experience
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type 1 effectiveness-implementation pilot trial of MBRP adapted for substance use peer workers compared to a standard of care (referral to 12-step) control condition
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Mindfulness Based Relapse PreventionMBRP for Peer Workers |
| Control Arm | Active comparator | Behavioral: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are > 18 years old
- Fluent in English
- Be currently employed in a substance use peer support role
- At-risk for SUD relapse as measured by a craving score of >15 on the adapted Penn Alcohol Craving Scale
Key exclusion criteria (2 listed)
- Have a cognitive impairment that jeopardizes informed consent
- Actively suicidal or psychotic
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 |
|---|---|---|
| Mindfulness Based Relapse PreventionMBRP for peer workers consists of 8 weekly 2-hour virtual sessions. | Behavioural | Intervention Arm |
| Standard of CareReferral to 12-step programming | Behavioural | Control Arm |
Primary outcome
Change from baseline in biologically verified substance use at 1, 3, and 6 months as measured by Saliva Drug Assays
Time frame: From enrollment to 6 months
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.
Change from baseline in self-reported substance use days at 1, 3, and 6 months as measured by the Timeline Follow-Back (TLFB)
Time frame: From enrollment to 6 months
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.
Change from baseline in relapse warning Signs at 1, 3, and 6 months as measured by the Advance Warning of Relapse (AWARE) Questionnaire
Time frame: From enrollment to 6 months
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).
Change from baseline in professional quality of life at 1, 3, and 6 months as measured by the Professional Quality of Life Scale (ProQOL)
Time frame: From enrollment to 6 months
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.
Post-intervention perceived feasibility of the intervention as measured by the Feasibility of Intervention Measure (FIM)
Time frame: Immediately after the final intervention session
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).
Post-intervention perceived acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
Time frame: Immediately after the final intervention session
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).
5 secondary outcomes
Change from baseline in the coping score assessed by the Brief-COPE measure at 6 months
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
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
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
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
Time frame: From enrollment to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 24611847Witkiewitz K, Bowen S, Harrop EN, Douglas H, Enkema M, Sedgwick C. Mindfulness-based treatment to prevent addictive behavior relapse: theoretical models and hypothesized mechanisms of change. Subst Use Misuse. 2014 Apr;49(5):513-24. doi: 10.3109/10826084.2014.891845.
- Background: PubMed 24647726Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, Carroll HA, Harrop E, Collins SE, Lustyk MK, Larimer ME. Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):547-56. doi: 10.1001/jamapsychiatry.2013.4546.
- Background: PubMed 19904665Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.
- Background: PubMed 28727663Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Relapse Prevention in people with Relapse/Recurrence and Substance Use (Drugs, Alcohol), run by University of Texas at Austin at 1 site in United States.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie A McCormick, PhD, MSW ((512) 471-5457, katie.mccormick@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in biologically verified substance use at 1, 3, and 6 months as measured by Saliva Drug Assays (time frame: From enrollment to 6 months). The study lists 6 primary outcomes in all. 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 NCT07741825, which also lists 4 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 7 Aug 2026.