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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/PSYCHIATRY/PSYCHIATRY | Other Identifier | UW Madison | |
| Protocol Version 6/30/23 | Other Identifier | UW Madison |
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prioritizing other opportunities
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| Name | Class |
|---|---|
| Center for Healthy Minds | OTHER |
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The goal of this clinical trial is to see whether the Healthy Minds Program for Addictions could be used to help veterans with moderate-severe opioid use disorder and post-traumatic stress disorder stay on buprenorphine maintenance treatment.
Participants will be asked to complete a six-week program consisting of 6 weekly, 2-hour in-person group sessions, as well as assessments before the start of the sessions.
This is a 6-week, single-arm, single-center pilot study of the acceptability and efficacy of an adaptation of the Healthy Minds Program for Veterans with opioid use disorder on buprenorphine maintenance treatment.
Following the Screening Visit, eligible subjects will complete 6 in-person sessions over the course of 2 months. The first session will be an introductory session introducing the basics of the program. After the introductory session, there will be four weekly sessions, each dedicated to a different domain of the program - awareness, connection, insight, and purpose. Participants will be encouraged to practice daily anywhere from 5 to 30 minutes from a set of practices that will be available to them on a password protected website. The intervention will end with a closing session where participants will have the opportunity to reflect on their experience of the program and share feedback. Weekly sessions will be held in person and will be facilitated by an MD, PhD Psychiatrist and Neuroscientist with 8 years of mindfulness practice together with a certified Peer Support Specialist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 weeks of sessions | Experimental | Participants will be asked to attend 6 2-hour weekly in-person sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Minds Program for Addictions | Behavioral | The Healthy Minds Program for Addictions is a 6-week, hybrid version of the original Healthy Minds Program (HMP), in which all lessons are adapted from the original lessons available in the app and delivered exclusively in person over weekly group sessions. The HMP has >100 guided audio practices that address 4 constituents of wellbeing: awareness, connection, insight, and purpose. Study participants will have access to specific practices from the HMP that are particularly relevant to the needs of populations with substance use disorders and trauma. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in treatment | Number of participants who complete all 6 sessions, as measured through actual attendance. | Through study completion, up to 4 months |
| Change in predictors of relapse and recovery | The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients in treatment for a substance use disorder (SUD). The BAM includes items that assess risk factors for substance use (scores 0-24, higher scores meaning more risk), protective factors that support sobriety (scores 0-24, higher scores meaning more protection), and drug and alcohol use (scores 0-12, higher scores meaning more use). The BAM produces composite scores for the three aforementioned domains. | Baseline, 3 weeks, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in psychological distress - perceived stress | Stress will be measured using the 10-item NIH Perceived Stress Scale. Each question is scored from 0 (never) to 5 (very often). The total score ranges from 0 to 40, with higher scores indicating higher levels of stress. | Baseline, 3 weeks, 6 weeks |
| Change in psychological distress - anxiety and depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Juergens, MD | University of Wisconsin, Madison | Principal Investigator |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Anxiety and depression will be measured using the Patient Reported Outcomes Measurement Information Systems (PROMIS) Anxiety and Depression scales. The investigators will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety. |
| Baseline, 3 weeks, 6 weeks |
| Change in PTSD symptoms | PTSD symptoms will be measured by the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5). The PCL-5 uses a 5-point Likert scale ranging from 0-4 for each symptom. Respondents rate how bothered they have been by each item in the past month. The items are summed to provide a total severity score ranging from 0-80. Higher scores indicate a higher level of symptoms. | Baseline, 3 weeks, 6 weeks |
| Change in well-being | Well-being will be measured using the 17-item Healthy Minds Index (HMI). The HMI assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. | Baseline, 3 weeks, 6 weeks |