ABSTRACT
BACKGROUND: Office-based opioid treatment with buprenorphine has emerged as a popular evidence-based treatment for opioid use disorder. Unfortunately, psychosocial stress, anxiety, pain, and co-morbid substance use increase patients' risk for relapse. We designed this study to compare the effects of complementing buprenorphine treatment with 24 weeks of a live-online Mindful Recovery Opioid Care Continuum (M-ROCC) group to a time and attention-matched, live-online Recovery Support Group (RSG) active control condition. METHODS: We plan to enroll a maximum of N = 280 and randomize at least N = 192 patients prescribed buprenorphine through referrals from office-based and telemedicine buprenorphine treatment providers and social media advertisements. Participants will be randomly assigned to M-ROCC or RSG and will be blinded to their treatment condition. The primary outcome for this study will be biochemically confirmed periods of abstinence from illicit opioids, as measured by self-reported use and randomly collected, video-observed oral fluid toxicology testing during the final 12 weeks of study participation. Secondary outcomes include changes in Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and pain interference scores between baseline and week 24. RESULTS: The trial was funded by the National Institutes of Health, HEAL Initiative through NCCIH (R33AT010125). Data collection is projected to end by September 2023, and we expect publication of results in 2024. CONCLUSION: If the M-ROCC intervention is found to be effective in this format, it will demonstrate that live-online mindfulness groups can improve outcomes and address common co-morbidities like anxiety and pain during buprenorphine treatment.
Subject(s)
Buprenorphine , Mindfulness , Opioid-Related Disorders , Humans , Buprenorphine/therapeutic use , Analgesics, Opioid/therapeutic use , Neoplasm Recurrence, Local , Opioid-Related Disorders/drug therapy , Anxiety , PainABSTRACT
BACKGROUND: The COVID-19 pandemic involved a prolonged period of collective trauma and stress during which substantial increases in mental health concerns, like depression and anxiety, were observed across the population. In this context, CHAMindWell was developed as a web-based intervention to improve resilience and reduce symptom severity among a public health care system's patient population. OBJECTIVE: This program evaluation was conducted to explore participants' engagement with and outcomes from CHAMindWell by retrospectively examining demographic information and mental health symptom severity scores throughout program participation. METHODS: We examined participants' symptom severity scores from repeated, web-based symptom screenings through Computerized Adaptive Testing for Mental Health (CAT-MH) surveys, and categorized participants into symptom severity-based tiers (tier 1=asymptomatic to mild; tier 2=moderate; and tier 3=severe). Participants were provided tier-based mindfulness resources, treatment recommendations, and referrals. Logistic regressions were conducted to evaluate associations between demographic variables and survey completion. The McNemar exact test and paired sample t tests were performed to evaluate changes in the numbers of participants in tier 1 versus tier 2 or 3 and changes in depression, anxiety, and posttraumatic stress disorder severity scores between baseline and follow-up. RESULTS: The program enrolled 903 participants (664/903, 73.5% female; 556/903, 61.6% White; 113/903, 12.5% Black; 84/903, 9.3% Asian; 7/903, 0.8% Native; 36/903, 4% other; and 227/903, 25.1% Hispanic) between December 16, 2020, and March 17, 2022. Of those, 623 (69%) completed a baseline CAT-MH survey, and 196 completed at least one follow-up survey 3 to 6 months after baseline. White racial identity was associated with completing baseline CAT-MH (odds ratio [OR] 1.80, 95% CI 1.14-2.84; P=.01). Participants' odds of having symptom severity below the clinical threshold (ie, tier 1) were significantly greater at follow-up (OR 2.60, 95% CI 1.40-5.08; P=.001), and significant reductions were observed across symptom domains over time. CONCLUSIONS: CHAMindWell is associated with reduced severity of mental health symptoms. Future work should aim to address program engagement inequities and attrition and compare the impacts of CHAMindWell to a control condition to better characterize its effects.