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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
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.
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.
Gaudenzia, Inc. (West Chester House)
West Chester, Pennsylvania, United States
Adherence to Medication Assisted Treatment (MAT)
Whether participant received MAT during post-residential-treatment discharge follow-up phase
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).