Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2022-01-04
2024-08-31
Brief Summary
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The purpose of this study is as follows:
1. Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program (n=120) or Twelve Step Facilitation (n=120).
2. Determine whether the MiMP: a) improves adherence to MOUD b) reduces the rate of relapse and cravings c) decreases self-reported anxiety, stress, and depression and d) reduces cortisol levels and cortisol reactivity to drug cues.
3. Examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.
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Detailed Description
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The goal of the proposed study is to determine the effectiveness of a mindfulness-based intervention that also utilizes peer mentors in addition to professional substance abuse therapists (the Minds and Mentors program \[MiMP\]) in improving adherence to MOUD and reducing relapse rates in a sample of individuals with OUD who are also on MOUD versus a twelve-step facilitation (TSF) program. The MiMP is a twelve-week intervention that uses group therapy and meets once a week for about two hours. The primary outcome measure will is adherence to medications for OUD. The secondary outcome measures will include the demographic covariates, depression, anxiety, stress, quality of life, and cravings. Finally, exploratory outcome measures will include cortisol levels and rates of reactivity to drug cues. This study will randomize participants in either intervention or control group in blocks of five. Data collection will occur at baseline, 8 weeks, 12 weeks (end of treatment) and at 12- week and 24- week follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mindfulness based relapse prevention and peer mentoring
Treatment will utilize a group format. The twelve-week mindfulness based relapsed prevention group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, followed by group sessions led by peer mentors for an additional four weeks.
Minds and Mentors
Participants will be randomized into Minds and Mentors to attend weekly group therapy sessions for 12 week. The mindfulness-based relapse prevention therapy intervention will be led by a licensed counselor for eights weeks followed up by four additional sessions led by a certified recovery support specialist (peer mentor).
12 Step Treatment Program
Participants in the attentional control group will attend 12 weeks of a enhanced 12 step treatment program.
Twelve Step Intervention Group
Participants will be randomized to the Twelve Step Intervention Group to attend weekly group therapy sessions for 12 week. The twelve step intervention group will be led by a licensed counselor.
Interventions
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Minds and Mentors
Participants will be randomized into Minds and Mentors to attend weekly group therapy sessions for 12 week. The mindfulness-based relapse prevention therapy intervention will be led by a licensed counselor for eights weeks followed up by four additional sessions led by a certified recovery support specialist (peer mentor).
Twelve Step Intervention Group
Participants will be randomized to the Twelve Step Intervention Group to attend weekly group therapy sessions for 12 week. The twelve step intervention group will be led by a licensed counselor.
Eligibility Criteria
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Inclusion Criteria
2. Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
3. Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
4. Are within maintenance phase of MOUD (not actively detoxing)
5. May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
6. Capable of reading and understanding English
7. Able to provide written informed consent (i.e. no surrogate)
8. Access to a smartphone or a computer with an internet connection
9. Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total)
Exclusion Criteria
2. Women who are pregnant (does not impact eligibility post study initiation)
3. Actively suicidal or homicidal
4. Active psychosis and/ or
5. Unstable medical conditions that contraindicate proposed treatment
Subject Exit criteria:
1. Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
2. Newly developed active suicidal or homicidal ideation
4. Inability to return for therapy sessions for four consecutive weeks.
19 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Tuscaloosa Veterans Affairs Medical Center
FED
Pathway Healthcare, LLC
UNKNOWN
University of Alabama, Tuscaloosa
OTHER
Responsible Party
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Mercy N. Mumba
Associate Professor of Nursing
Locations
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Birmingham Veteran Affairs Medical Center
Birmingham, Alabama, United States
Pathway Healthcare, LLC
Birmingham, Alabama, United States
Tuscaloosa Veteran Affairs Medical Center
Tuscaloosa, Alabama, United States
University of Alabama
Tuscaloosa, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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