Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder

Mindful MAT Adherence: Mindfulness-Based Relapse Prevention (MBRP) to Improve Extended-release Naltrexone (XR-NTX) Adherence and Drug-use Outcomes for Opioid Use Disorder (OUD)

This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a ~60-day residential addiction treatment program. Participant recruitment will prioritize participants that are prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA); Behavioral: Treatment-As-Usual

Detailed Description

Medically detoxified OUD patients enrolling into a ~60-day residential program will be randomized to either MAT Treatment-As-Usual (TAU; n=100) or TAU+MBRP (MBRP; n=100) as part of their residential treatment and followed for 3-months post-discharge to assess MAT adherence and drug-use. All participants (n=200) will participate in residential TAU (i.e., MAT, supportive group therapy), and will be monitored following residential discharge to assess MAT adherence and drug-use relapse. Participants will complete assessments at baseline, post- treatment, and 1-, 2-, and 3-month follow-ups. Study Aims include:

AIM 1 (PRIMARY): Compare impact of TAU versus TAU+MBRP on medication adherence and drug-use outcomes. Hypotheses: Relative to TAU, TAU+MBRP participants will demonstrate a) greater MAT adherence measured at follow-up timepoints, and b) reduced drug-use (i.e., self-report, urine drug-screens [UDS]) measured at discharge and follow-up timepoints. AIM 2: Determine whether the beneficial effects of TAU+MBRP on outcome are mediated by improvements in opioid craving and dispositional mindfulness. Hypotheses: TAU+MBRP participants will report greater improvements in distress tolerance and mindfulness, relative to TAU, which will mediate treatment outcomes (i.e., MAT adherence, reduced drug use and positive-UDS). EXPLORATORY AIM 3: Determine effects of baseline factors on treatment outcomes. Hypotheses: More severe trauma exposure (i.e., increased number of traumas) and greater posttraumatic stress symptom severity will result in poorer treatment adherence (i.e., reduced MAT follow-up appointments) and worse drug-use outcomes (i.e., increased self-reported drug use, positive-urine drug-screens) throughout each the follow-up assessments among TAU participants but not among MBRP participants.

Study Design Overview: In an randomized controlled trial design, patients enrolling into a residential addiction treatment center will be randomized to TAU (i.e., MAT, supportive group therapy) or TAU+MBRP with comparisons being made between MBRP (n=100) and treatment-as-usual (TAU; n=100) on assessment measures collected at baseline, prior to residential discharge, and at 1, 2, and 3-month follow-up time points. To address AIM 1 (TAU+MBRP, Adherence and Drug-Use): participants will be randomly assigned to receive TAU or MBRP+TAU, during their residence within an inpatient treatment setting and will complete assessments at enrollment, prior to discharge, and at 1, 2, and 3-months follow-up to assess MAT adherence and drug-use. Comparisons, on assessment measures collected at follow-up, will be made between treatment conditions to determine if MBRP+TAU results in greater number MAT adherence, fewer positive UDS, reduced drug-craving, and increased mindfulness. AIM 2 (MBRP Mechanisms of Change): Will determine whether the beneficial effects of MBRP on treatment outcome (i.e., MAT adherence, drug-use) are mediated by increases in mindfulness and distress tolerance. AIM 3 (Predictors of MAT Adherence): will examine the extent to which prior trauma-exposure and PTSD symptom severity moderates MAT adherence and drug-use outcomes, among TAU participants (but not MBRP participants), following discharge from residential treatment.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • West Chester, Pennsylvania, United States, 19382
      • Gaudenzia, Inc. (West Chester House)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. An informed consent document voluntarily signed and dated by the subject.
2. Subject must understand and be able to read and write in English.
3. Enrollment in residential treatment at study site.
4. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
5. Subject must be willing to be randomized to treatment condition.
6. Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

1. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview.
2. Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA); Group intervention comprised of didactics and trainings in cognitive behavioral therapy relapse prevention skills and mindfulness meditation.	Behavioral: Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA); Integrates evidenced-based practices to decrease the probability and severity of relapse for those in addiction recovery. MBRP incorporates components from CBT relapse prevention and includes training in meditation practices as a means to foster increased awareness of emotional and cognitive experiences. MBRP also includes training in brief informal meditations aimed at increasing awareness and adaptive response to drug cues and negative affect.
Active Comparator: Treatment-As-Usual (TAU); Standard procedure for residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on issues related to mental health and substance use disorders; and medication counseling. No aspect of the treatment-as-usual services provided entails mindfulness training or components of mindfulness training.	Behavioral: Treatment-As-Usual; Standard treatment programming procedures for all individuals residing within the residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on general issues related to mental health and SUDs; and medication counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Medication Assisted Treatment (MAT)	Whether participant received MAT during post-residential-treatment discharge follow-up phase	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Adherence to Medication Assisted Treatment (MAT)	Whether participant received MAT during post-residential-treatment discharge follow-up phase	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Adherence to Medication Assisted Treatment (MAT)	Whether participant received MAT during post-residential-treatment discharge follow-up phase	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Opioid Drug Use	Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Opioid Drug Use	Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Opioid Drug Use	Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Opioid Craving	Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Opioid Craving	Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.	Assessed 1-month following discharge from residential addiction treatment facility (approximately 30 days post discharge)
Opioid Craving	Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post discharge)
Opioid Craving	Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dispositional Mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Dispositional Mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Dispositional Mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.	Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Dispositional Mindfulness	Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported.	Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Global Mental Health	Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Global Mental Health	Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Global Mental Health	Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Global Mental Health	Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Reward Probability Inventory: Reward Probability	Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Reward Probability Inventory: Reward Probability	Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Reward Probability Inventory: Reward Probability	Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Reward Probability Inventory: Reward Probability	Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Reward Probability Inventory: Environmental Suppression	Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Reward Probability Inventory: Environmental Suppression	Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Reward Probability Inventory: Environmental Suppression	Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Reward Probability Inventory: Environmental Suppression	Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Abstinence Self-Efficacy	Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.	Assessed immediately prior to discharge from residential addiction treatment facility.
Abstinence Self-Efficacy	Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Abstinence Self-Efficacy	Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Abstinence Self-Efficacy	Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Posttraumatic Stress Severity	Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Posttraumatic Stress Severity	Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Posttraumatic Stress Severity	Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Posttraumatic Stress Severity	Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Trauma Symptoms of Discrimination	Trauma Symptoms of Discrimination Scale (TSDS; Williams, Printz, et al., 2018), 21-item self-report measure of dysfunctional anxiety and avoidance due to fears of discrimination. Higher scores = worse, greater distress related to discrimination; Range: 21-84. Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Treatment Engagement	Post-Discharge (follow-up) treatment engagement. A 3-item self-report questionnaire recorded engagement in individual therapy, group therapy, and/or alcoholics/narcotics anonymous support groups following residential discharge (i.e., follow-up). Scores range from 0 (no engagement in any services) to 3 (engagement in all three services) over the past month. Higher scores reflect greater engagement in mental health services following discharge.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Treatment Engagement	Post-Discharge (follow-up) treatment engagement. A 3-item self-report questionnaire recorded engagement in individual therapy, group therapy, and/or alcoholics/narcotics anonymous support groups following residential discharge (i.e., follow-up). Scores range from 0 (no engagement in any services) to 3 (engagement in all three services) over the past month. Higher scores reflect greater engagement in mental health services following discharge.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Treatment Engagement	Post-Discharge (follow-up) treatment engagement. A 3-item self-report questionnaire recorded engagement in individual therapy, group therapy, and/or alcoholics/narcotics anonymous support groups following residential discharge (i.e., follow-up). Scores range from 0 (no engagement in any services) to 3 (engagement in all three services) over the past month. Higher scores reflect greater engagement in mental health services following discharge.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Mindfulness of Craving	Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.	Assessed immediately prior to discharge from residential addiction treatment facility.
Mindfulness of Craving	Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.	Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
Mindfulness of Craving	Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.	Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
Mindfulness of Craving	Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported.	Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MBRP Adherence and Competence Scale (MBRP-AC): Adherence Subscale	The MBRP-AC (Chawla et al., 2010) rating tool was used by independent raters to code therapists' adherence to MBRP treatment components (i.e., leading specific meditation practices, facilitating discussion of key concepts). An additional adherence item assessed for the presence of MOUD discussion. Adherence items were coded using a dichotomous scale (i.e., present vs absent; no evidence vs more than sufficient evidence). Two doctoral students independently evaluated MBRP-RA adherence and two licensed clinical psychologists, experienced in MBRP, independently evaluated MBRP adherence (no evidence vs sufficient evidence). Two iterations of each of the eight MBRP-RA session modules were randomly selected for review. An overall adherence score was generated by summing and dividing by the total number of components to determine the percentage of components adhered to. The values between the independent coders were averaged.	MBRP audiorecorded sessions occurred throughout the duration of the study up to 3 years; randomly selected recordings were coded for Adherence. These recordings were evaluated for adherence after the study concluded and MBRP was no longer being delivered
MBRP Adherence and Competence (MBRP-AC): Competence Subscale	The MBRP-AC (Chawla et al., 2010) rating tool was used by independent raters to code therapists' competence in MBRP treatment delivery (i.e., evaluation of overall session quality). Two licensed clinical psychologists, with expertise in MBRP, independently evaluated MBRP competence components. Two iterations of each of the eight MBRP-RA session modules were randomly selected for review. Competence scale items were coded using a Likert-type scale (0 = Not satisfactory/mediocre, 1 = Satisfactory, 2 = Good/excellent). The scale range for competence is from 0 to 2 with a higher score representing higher competence and a better outcome.	MBRP audiorecorded sessions occurred throughout the duration of the study up to 3 years; randomly selected recordings were coded for Adherence. These recordings were evaluated for competence after the study concluded and MBRP was no longer being delivered

Collaborators and Investigators

• Sponsor: West Chester University of Pennsylvania
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Michael J Gawrysiak, PhD, West Chester University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Opioid; Addiction; Relapse Prevention
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Opioid-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: R15DA050102 (U.S. NIH Grant/Contract); 1R15DA050102-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After all primary analyses and reports have been generated by the study PI to satisfy the aims of the research proposal, the PI will accept requests for components of the data to be available to other researchers for secondary analyses. When appropriate, the PI will share information necessary to foster productive collaborations.
• IPD Sharing Time Frame: When deemed appropriate by the study PI, data will be available after all primary research questions, statistical analyses, and publications have been completed.
• IPD Sharing Access Criteria: Submission of a formal request to the study PI indicating what specific information is requested and what the intentions are for use of this data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

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