Trial Outcomes & Findings for Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder (NCT NCT05042388)

Recruitment of prospective participants occurred in the context of a residential addiction treatment facility located in the Mid-Atlantic region of the U.S. Prospective participants were notified of the study through a combination of study flyers posted in common spaces in the residential facility and through staff informing prospective participants of study enrollment, pending eligibility screening. Recruitment occurred between 8/1/21 to 8/20/24.

One hundred eighty-seven participants were partially or fully evaluated to determine eligibility for study participation of which 82 were designated as ineligible: 48 excluded due to ineligibility, 6 excluded at the discretion of the study PI (i.e., adversarial behavior and/or noncompliance during eligibility assessment), 28 were excluded by virtue of being discharged prematurely from the residential facility, thereby failing to complete eligibility screening.

Not all participants completed this measure at baseline due to this measure being added after the study start date and/or due to participant omission of measure completion.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.