Mindfulness-based Relapse Prevention for Peer Workers

NCT07741825 | Recruiting

• 2 other identifiers: STUDY000090021K01DA065810-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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:

• 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

Keywords

Mindfulness Based Relapse Prevention; Peer Recovery Specialist; Peer Worker; Coping Skills; Relapse; Recovery; Recovery Capital; Occupational Stress; Mindfulness

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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).

  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.

  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).

  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).

  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

  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

  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

  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

  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

  From enrollment to 6 months

Other Outcomes (3)

• Change from baseline in mean score of mental health assessed by the Behavior and Symptom Identification Scale (BASIS-24) measure at 6 months

  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

  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

  From enrollment to 6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

MBRP for Peer Workers

Behavioral: Mindfulness Based Relapse Prevention

Control Arm

ACTIVE COMPARATOR

Standard of Care

Behavioral: Standard of Care

Interventions

Mindfulness Based Relapse Prevention BEHAVIORAL

MBRP for peer workers consists of 8 weekly 2-hour virtual sessions.

Intervention Arm

Standard of Care BEHAVIORAL

Referral to 12-step programming

Control Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have a cognitive impairment that jeopardizes informed consent
• Actively suicidal or psychotic

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Addiction Research Institute

Austin, Texas, 78712, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 24611847 BACKGROUND

• Bowen 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.

  PMID: 24647726 BACKGROUND

• Bowen 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.

  PMID: 19904665 BACKGROUND

• Grant 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.

  PMID: 28727663 BACKGROUND

MeSH Terms

Conditions

Recurrence; Substance-Related Disorders; Burnout, Psychological; Occupational Stress

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Occupational Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Katie A McCormick, PhD, MSW

CONTACT

(512) 471-5457; katie.mccormick@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)