Trial Outcomes & Findings for Minds and Mentors Program (MiMP)- R61 (NCT NCT04233671)

NCT ID: NCT04233671

Last Updated: 2023-07-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Last 4 weeks of the intervention period
• Results posted on: 2023-07-21

Participant Flow

We consented 43 participants total over the course of the study. However, participants were only considered enrolled in the study once they completed their baseline data collection and were ready to be randomized. Therefore, there were some participants who signed informed consent but did not follow through to complete baseline data collection. We had 21 participants who followed through and completed the baseline data collection. These were considered enrolled in the study.

Participant milestones

Measure	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. 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.	12 Step Treatment Program Control The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Overall Study STARTED	13	8
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minds and Mentors Program (MiMP)- R61

Baseline characteristics by cohort

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=13 Participants 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. 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.	12 Step Treatment Program Control n=8 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.	Total n=21 Participants Total of all reporting groups
Age, Continuous	45.54 years STANDARD_DEVIATION 11.93 • n=5 Participants	40.38 years STANDARD_DEVIATION 13.15 • n=7 Participants	43.57 years STANDARD_DEVIATION 12.34 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Last 4 weeks of the intervention period

Population: comparing means for the number of days participants were adherent to MOUD at week 12 (end of intervention). These data are accurate. All participants in the mindfulness-based relapse prevention and peer mentoring arm reported taking medications for 28 days.

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=8 Participants 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. 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.	12 Step Treatment Program Control n=4 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Number of Days Adherence to Medication Assisted Treatment	28 days Standard Deviation 0	23.25 days Standard Deviation 9.5

SECONDARY outcome

Timeframe: 12 months

Retention rate (the number of participants completing T4 divided by the number who were randomized for each treatment arm)

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=13 Participants 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. 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.	12 Step Treatment Program Control n=8 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Feasibility of Mindfulness Based Relapse Prevention as Measured by Retention Rate	8 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 months - at the end of the 12 week intervention

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

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=8 Participants 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. 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.	12 Step Treatment Program Control n=4 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Acceptability and Adherence to Mindfulness Based Relapse Prevention as Measured by the Treatment Acceptability/Adherence (TAAS) Scale	71 score on a scale Standard Error 5.6	78 score on a scale Standard Error 9.8

SECONDARY outcome

Timeframe: 3 months - at the end of the 12 week intervention

Population: data were present for this variable for 11 participants total. 1 participants did not provide data on this outcome variable.

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=7 Participants 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. 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.	12 Step Treatment Program Control n=4 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Satisfaction With the Intervention Program	28.9 score on a scale Standard Error 1.1	30.8 score on a scale Standard Error 7.4

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=8 Participants 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. 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.	12 Step Treatment Program Control n=4 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Acceptability of the Intervention Programs	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Last four weeks of the 12-week intervention

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=8 Participants 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. 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.	12 Step Treatment Program Control n=4 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Relapse Rate (Number of Participants With Relapse) as Determined by Urine Drug Screen	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=8 Participants 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. 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.	12 Step Treatment Program Control n=4 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Relapse Rate (Number of Participants With Relapse) as Measured Via Self-report	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: data were present for this variable for 10 participants total. 2 participants did not provide data on this outcome variable.

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=7 Participants 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. 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.	12 Step Treatment Program Control n=3 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Opioid Cravings as Measured by the Opioid Craving Scale	2.2 score on a scale Standard Error 0.9	3.9 score on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: 6 months

Population: data were present for this variable for 10 participants total. 2 participants did not provide data on this outcome variable.

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=7 Participants 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. 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.	12 Step Treatment Program Control n=3 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Social Support as Measured by the Community Assessment Inventory	35.7 score on a scale Standard Error 1.5	27.0 score on a scale Standard Error 4.9

SECONDARY outcome

Timeframe: 6 months

Population: data were present for this variable for 10 participants total. 2 participants did not provide data on this outcome variable.

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=7 Participants 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. 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.	12 Step Treatment Program Control n=3 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Depression as Measured by the Patient Health Questionnaire	8.6 score on a scale Standard Error 2.5	12.7 score on a scale Standard Error 6.4

SECONDARY outcome

Timeframe: 6 months

Population: data were present for this variable for 10 participants total. 2 participants did not provide data on this outcome variable.

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=7 Participants 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. 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.	12 Step Treatment Program Control n=3 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Stress as Measured by the Perceived Stress Scale	20.6 score on a scale Standard Error 1.5	25.7 score on a scale Standard Error 3.8

SECONDARY outcome

Timeframe: 6 months

Population: data were present for this variable for 10 participants total. 2 participants did not provide data on this outcome variable.

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=7 Participants 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. 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.	12 Step Treatment Program Control n=3 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Anxiety as Measured by the Generalized Anxiety Disorder Scale	6.4 score on a scale Standard Error 1.8	12.7 score on a scale Standard Error 5.9

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=43 Participants 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. 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.	12 Step Treatment Program Control The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Feasibility of Mindfulness-based Relapse Prevention as Measured by Randomization Rate	21 Participants	—

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=120 Participants 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. 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.	12 Step Treatment Program Control The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Feasibility of Mindfulness-based Relapse Prevention as Measured by Enrollment Rate	43 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline data collection

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.

Outcome measures

Measure	Mindfulness Based Relapse Prevention and Peer Mentoring n=8 Participants 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. 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.	12 Step Treatment Program Control n=4 Participants The control group will meet for 12 weeks for standard 12 Step Facilitation meetings.
Baseline Cortisol Reactivity to Drug Cues	-.0837 microgram/dL Standard Deviation .132	-.0045 microgram/dL Standard Deviation .063

Adverse Events

Mindfulness Based Relapse Prevention and Peer Mentoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

12 Step Treatment Program Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mercy Mumba

The University of Alabama

Phone: 205-348-6317

Email: mnmumba@ua.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place