Back to resultsMinds and Mentors Program (MiMP)- R61 (MiMP)
Primary Purpose
Opioid-use Disorder, Medication Assisted Treatment, Substance Use Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness based relapse prevention and peer mentoring
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring Opioid Use Disorder, Mindfulness based therapy, cravings, relapse prevention, treatment retention, depression, stress, anxiety, cortisol, peer mentors
Eligibility Criteria
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.
Sites / Locations
- Pathway Healthcare, LLC
- Fritz Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness based relapse prevention and peer mentoring
12 Step Treatment Program Control
Arm Description
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.
The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04233671
First Posted
January 15, 2020
Last Updated
June 29, 2023
Sponsor
University of Alabama, Tuscaloosa
Collaborators
University of Alabama at Birmingham, Tuscaloosa Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04233671
Brief Title
Minds and Mentors Program (MiMP)- R61
Acronym
MiMP
Official Title
A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders- R61
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama, Tuscaloosa
Collaborators
University of Alabama at Birmingham, Tuscaloosa Veterans Affairs Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The proposed research effort will:
The purpose of this study is as follows:
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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Medication Assisted Treatment, Substance Use Disorders
Keywords
Opioid Use Disorder, Mindfulness based therapy, cravings, relapse prevention, treatment retention, depression, stress, anxiety, cortisol, peer mentors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional Study Model: Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based relapse prevention and peer mentoring
Arm Type
Experimental
Arm Description
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.
Arm Title
12 Step Treatment Program Control
Arm Type
No Intervention
Arm Description
The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based relapse prevention and peer mentoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Days Adherence to Medication Assisted Treatment
Description
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.
Time Frame
Last 4 weeks of the intervention period
Secondary Outcome Measure Information:
Title
Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate
Description
Retention rate (the number of participants completing T4 divided by the number who were randomized for each treatment arm)
Time Frame
12 months
Title
Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale
Description
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
Time Frame
3 months - at the end of the 12 week intervention
Title
Satisfaction With the Intervention Program
Description
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.
Time Frame
3 months - at the end of the 12 week intervention
Title
Acceptability of the Intervention Programs
Description
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.
Time Frame
3 months
Title
Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen
Description
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.
Time Frame
Last four weeks of the 12-week intervention
Title
Relapse Rate (Number of Participants With Relapse) as Measured Via Self-report
Description
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.
Time Frame
3 months
Title
Opioid Cravings as Measured by the Opioid Craving Scale
Description
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.
Time Frame
6 months
Title
Social Support as Measured by the Community Assessment Inventory
Description
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.
Time Frame
6 months
Title
Depression as Measured by the Patient Health Questionnaire
Description
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.
Time Frame
6 months
Title
Stress as Measured by the Perceived Stress Scale
Description
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.
Time Frame
6 months
Title
Anxiety as Measured by the Generalized Anxiety Disorder Scale
Description
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.
Time Frame
6 months
Title
Feasibility of Mindfulness-based Relapse Prevention as Measured by Randomization Rate
Description
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.
Time Frame
12 months
Title
Feasibility of Mindfulness-based Relapse Prevention as Measured by Enrollment Rate
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Baseline Cortisol Reactivity to Drug Cues
Description
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.
Time Frame
at baseline data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercy N Mumba, PhD
Organizational Affiliation
University of Alabama, Tuscaloosa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pathway Healthcare, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Fritz Clinic
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Minds and Mentors Program (MiMP)- R61
We'll reach out to this number within 24 hrs