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Completed

NCT Number: NCT05042388

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

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.

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Key information

Conditions

Opioid-use Disorder Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaudenzia, Inc. (West Chester House)

West Chester, Pennsylvania, 19382, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An informed consent document voluntarily signed and dated by the subject.
  • Subject must understand and be able to read and write in English.
  • Enrollment in residential treatment at study site.
  • 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.
  • Subject must be willing to be randomized to treatment condition.
  • Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)

Behavioral

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.

Treatment-as-usual

Behavioral

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.

Primary outcomes

  1. Adherence to Medication Assisted Treatment (MAT)

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    Whether participant received MAT during post-residential-treatment discharge follow-up phase

  2. Adherence to Medication Assisted Treatment (MAT)

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    Whether participant received MAT during post-residential-treatment discharge follow-up phase

  3. Adherence to Medication Assisted Treatment (MAT)

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    Whether participant received MAT during post-residential-treatment discharge follow-up phase

  4. Opioid Drug Use

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  5. Opioid Drug Use

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  6. Opioid Drug Use

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

  7. Opioid Craving

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  8. Opioid Craving

    Time frame: Assessed 1-month following discharge from residential addiction treatment facility (approximately 30 days post discharge)

    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.

  9. Opioid Craving

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post discharge)

    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.

  10. Opioid Craving

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post discharge)

    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.

Secondary outcomes

  1. Dispositional Mindfulness

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  2. Dispositional Mindfulness

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  3. Dispositional Mindfulness

    Time frame: Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  4. Dispositional Mindfulness

    Time frame: Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

  5. Global Mental Health

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  6. Global Mental Health

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  7. Global Mental Health

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  8. Global Mental Health

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

  9. Reward Probability Inventory: Reward Probability

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  10. Reward Probability Inventory: Reward Probability

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  11. Reward Probability Inventory: Reward Probability

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  12. Reward Probability Inventory: Reward Probability

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

  13. Reward Probability Inventory: Environmental Suppression

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  14. Reward Probability Inventory: Environmental Suppression

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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

  15. Reward Probability Inventory: Environmental Suppression

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  16. Reward Probability Inventory: Environmental Suppression

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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

  17. Abstinence Self-Efficacy

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  18. Abstinence Self-Efficacy

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  19. Abstinence Self-Efficacy

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  20. Abstinence Self-Efficacy

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

  21. Posttraumatic Stress Severity

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  22. Posttraumatic Stress Severity

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  23. Posttraumatic Stress Severity

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  24. Posttraumatic Stress Severity

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

  25. Trauma Symptoms of Discrimination

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  26. Treatment Engagement

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  27. Treatment Engagement

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  28. Treatment Engagement

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

  29. Mindfulness of Craving

    Time frame: Assessed immediately prior to discharge from residential addiction treatment facility.

    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.

  30. Mindfulness of Craving

    Time frame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

    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.

  31. Mindfulness of Craving

    Time frame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

    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.

  32. Mindfulness of Craving

    Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

    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.

Other outcomes

  1. MBRP Adherence and Competence Scale (MBRP-AC): Adherence Subscale

    Time frame: 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

    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.

  2. MBRP Adherence and Competence (MBRP-AC): Competence Subscale

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

West Chester University of Pennsylvania

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2021
Registry last updated
Mar 31, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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