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Recruiting NCT07741825

Mindfulness-based Relapse Prevention for Peer Workers

No phase Interventional Relapse/Recurrence Substance Use (Drugs, Alcohol) Burnout

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Based Relapse Prevention, Standard of Care.
Who it may be relevant to
Registry conditions: Relapse/Recurrence, Substance Use (Drugs, Alcohol), Burnout. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Adapting and Pilot Testing Mindfulness-Based Relapse Prevention for Substance Use Peer Workers

Overview

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: 1. Identify the causes, consequences, and risk and protective factors for relapse among peer workers; 2. Identify peers' preferences related to MBRP content, structure, and delivery; 3. Adapt the MBRP intervention for peer workers; and 4. 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

Interventions

  • Behavioral Mindfulness Based Relapse Prevention
    MBRP for peer workers consists of 8 weekly 2-hour virtual sessions.
  • Behavioral Standard of Care
    Referral to 12-step programming

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • Post-intervention perceived feasibility of the intervention as measured by the Feasibility of Intervention Measure (FIM) [Time frame: Immediately after the final intervention session]
  • Post-intervention perceived acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM) [Time frame: Immediately after the final intervention session]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Addiction Research Institute — Austin

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. PMID 24611847
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07741825 · STUDY00009002 · 1K01DA065810-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗