Minds and Mentors Program (MiMP)- R61 (MiMP)

A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders- R61

The proposed research effort will:

The purpose of this study is as follows:

1. Test the feasibility and acceptability of a twelve- week mindfulness based relapse prevention protocol in combination with peer mentoring in individuals with opioid use disorder who are on medication assisted treatment.
2. Determine whether participation in a combination of mindfulness based relapse prevention and peer mentoring in comparison with an attentional control group: a) improves adherence to MAT b) decreases relapse and cravings c) improves psychosocial outcomes such as depression, anxiety, stress and social support

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Medication Assisted Treatment; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Mindfulness based relapse prevention and peer mentoring

Detailed Description

Although medication assisted therapy (MAT) for opioid use disorders (OUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MAT regimens remains a challenge. 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 MAT for OUD and reducing relapse rates in a sample of individuals with OUD who are also on MAT 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 for eight weeks with a professional substance abuse therapist; after the completion of eight therapist led sessions, participants will attend four weeks of group therapy sessions conducted by a peer mentor. The peer mentor will also attend the initial eight sessions with the therapist to establish rapport with participants. The control group will attend twelve weeks of a standard twelve-step facilitation program. This study will utilize an individually randomized group treatment design with ten participants in both the intervention and control groups. Data collection will occur at baseline, end of treatment, and at 3, 6, and 12- month follow-up.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Pathway Healthcare, LLC
    • Homewood, Alabama, United States, 35209
      • Fritz Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 19 years old.
• Opioid Use disorder diagnosis based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria in the past 30 days
• Currently receiving MAT for OUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
• Are within maintenance phase of MAT (not actively detoxing)
• 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
• Capable of reading and understanding English
• Able to provide written informed consent (i.e. no surrogate)
• Willing to commit to 8 group therapy sessions, baseline, and follow-up assessments for 12-months after the end of treatment (14- month total)

Exclusion Criteria:

• Significant cognitive impairment
• Women who are pregnant
• Actively suicidal or homicidal
• Active psychosis and/ or
• Unstable medical conditions that contraindicate proposed treatment

Subject exit criteria:

• Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
• Newly developed active suicidal or homicidal ideation
• Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial
• Inability to return for therapy sessions due to incarceration or hospitalization lasting longer than four weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness based relapse prevention and peer mentoring; MiMP is a twelve week program, meeting once per week for 12 weeks for approximately two hours. Eight weeks are facilitated by a licensed counselor, and four weeks are facilitated by a peer mentor.	Behavioral: Mindfulness based relapse prevention and peer mentoring; Importantly, the treatment will utilize a group format. Group process can serve as a vital agent in breaking down client denial about drug abuse problems. Groups have also been shown to be suitable for treating problems commonly associated with substance abuse, including depression, isolation, and shame. Additionally, groups intrinsically have many rewarding benefits, including reducing isolation and enabling members to witness the recovery of others. The eight-week group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, then followed by group sessions led by peer mentors for an additional four weeks.
No Intervention: 12 Step Treatment Program Control; The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days Adherence to Medication Assisted Treatment	The primary outcome variable is adherence to medication-assisted therapy (MAT), quantified as the number of days MAT was received as indicated during the last 4 weeks of the intervention period. We expect that this can be treated as a continuous variable in regression models.	Last 4 weeks of the intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate	Retention rate (the number of participants completing T4 divided by the number who were randomized for each treatment arm)	12 months
Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale	Scores on the TAAS are scored on a scale of 1-7. For ease of interpretation by our participants and for data entry purposes, we asked participants to rate the experience on a scale of 1-10. The composite sum score was used for each person. Therefore, scores ranged from 10 to 100. Higher numbers mean more treatment acceptability and adherence	3 months - at the end of the 12 week intervention
Satisfaction With the Intervention Program	Satisfaction with the intervention program will be assessed with the 8-item Client Satisfaction Questionnaire (CSQ-8). The total score will be computed by adding the 8 items for a composite score. The range for composite scores is from 8-32. Higher numbers mean more satisfied the participant is with the program.	3 months - at the end of the 12 week intervention
Acceptability of the Intervention Programs	Exit interviews were conducted with all participants to determine whether participants rated the intervention as acceptable. The number who rated each intervention as acceptable is reported.	3 months
Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen	Relapse will be measured during the last 4 weeks of the intervention period as determined by Urine Drug Screen (UDS). Participants were only considered relapsed if they had opiates (outside prescribed MOUD) or any other illicit substance detected in the urine drug screen during the last four weeks of the 12-week intervention.	Last four weeks of the 12-week intervention
Relapse Rate (Number of Participants With Relapse) as Measured Via Self-report	Relapse will be measured via self-report utilizing the Timeline Follow-back (TLFB). The total number of participants who self-reported relapse during the last four weeks of the intervention period per treatment arm.	3 months
Opioid Cravings as Measured by the Opioid Craving Scale	Cravings as measured by the Opioid Craving Scale (OCS), a modification of the Cocaine Craving Scale will be utilized to assess opioid craving. The OCS consists of three items rated on a visual analog scale from 0-10. The total score is calculated by averaging the three items. Higher means scores represent more craving.	6 months
Social Support as Measured by the Community Assessment Inventory	Social Support as measured by the Community Assessment Inventory (CAI) to assess perceived support. The original CAI contains 37 items covering support within four areas i.e., family living with and outside, friends, and communities, with items in each area summed to create the corresponding subscales. Lower scores indicate less support and higher scores indicate greater support. We will only evaluate community support for the current study (containing 13 items). Therefore, scores ranged from 13 to 52.	6 months
Depression as Measured by the Patient Health Questionnaire	Depression as measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report that measures depressive symptoms. The participant's score may range from 1- 27. The interpretation of the total score is as follows: 1-4, Minimal depression; 5-9, mild depression; 10-14, Moderate depression; 15-19, Moderately severe depression; 20-27, Severe depression. Higher numbers mean more depressive symptoms at 12 weeks post-end of intervention.	6 months
Stress as Measured by the Perceived Stress Scale	Stress as measured by the Perceived Stress Scale (PSS), a 10-item self-report of perceived stress. Scores may range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14 to 26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.	6 months
Anxiety as Measured by the Generalized Anxiety Disorder Scale	Anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7), a 7-item self-report of anxiety. The score for the seven items ranges from 0 to 21. Scores of 5-9 represent mild anxiety, 10- 14 represent Moderate anxiety, and scores greater than 15 represent severe anxiety. Higher numbers indicate higher anxiety at 12 weeks post-end of intervention.	6 months
Feasibility of Mindfulness-based Relapse Prevention as Measured by Randomization Rate	Randomization rate (the number of participants randomized divided by the number of participants who consented). Participants consented to hear about the study before screening for eligibility was conducted. This was based on how our protocol was written. Therefore, some of the people who consented did not end up meeting the eligibility criteria for the study, and therefore were not considered enrolled in the study. The difference between consented participants and the enrolled participants is due to the screen failures. Participants are also only considered randomized after they complete all baseline data collection, including providing biosamples. We have revised this protocol for the R33 phase to avoid the issue of screen failures after the consent process is completed.	12 months
Feasibility of Mindfulness-based Relapse Prevention as Measured by Enrollment Rate	Enrollment rate (the number of participants who sign the informed consent form divided by the number who are approached). Participants consented to hear about the study before screening for eligibility was conducted. This was based on how our protocol was written. Therefore, some of the people who consented did not end up meeting the eligibility criteria for the study, and therefore were not considered enrolled in the study. The difference between consented participants and the enrolled participants is due to the screen failures. Participants are also only considered randomized after they complete all baseline data collection, including providing biosamples. We have revised this protocol for the R33 phase to avoid the issue of screen failures after the consent process is completed.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Cortisol Reactivity to Drug Cues	Non-invasive salivary cortisol levels were assessed as a measure of stress reactivity to drug cues at baseline. A saliva sample was collected at baseline and again 20 minutes after watching a video depicting drug use. Saliva samples were assayed for cortisol levels. Cortisol reactivity for each participant was calculated using a difference score in which the baseline sample cortisol level was subtracted from the post-video sample cortisol level.	at baseline data collection

Collaborators and Investigators

• Sponsor: University of Alabama, Tuscaloosa
• Collaborators: University of Alabama at Birmingham; Tuscaloosa Veterans Affairs Medical Center
• Investigators: Principal Investigator: Mercy N Mumba, PhD, University of Alabama, Tuscaloosa

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: depression; relapse prevention; anxiety; stress; Opioid Use Disorder; Mindfulness based therapy; cravings; treatment retention; cortisol; peer mentors
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 1R61AT010802-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No