Literature Collection

IMPORTANCE: Adults with opioid use disorder (OUD), co-occurring with depression and/or posttraumatic stress disorder (PTSD), may benefit from collaborative care. Although collaborative care is an evidence-based model to treat behavioral health conditions in primary care, it has not been widely tested for OUD with co-occurring mental illness. OBJECTIVE: To determine whether collaborative care, tailored for low-resource settings, improves outcomes for patients with OUD and co-occurring depression and/or PTSD more so than enhanced usual care (EUC). DESIGN, SETTING, AND PARTICIPANTS: This 2-group single-masked pragmatic randomized clinical trial was conducted in 18 primary care clinics in California and New Mexico from January 8, 2021, to December 5, 2023, and included adult participants with probable OUD as well as major depression and/or PTSD. Data analysis was performed August 2024 to May 2025. INTERVENTIONS: Six months of a care manager and addiction psychiatrist working with a primary care practitioner to deliver evidence-based treatments for OUD, major depression, and PTSD; care managers were community health workers who monitored and addressed biopsychosocial symptoms and referred patients for psychotherapy. MAIN OUTCOMES AND MEASURES: Primary outcomes at 6 months were time to first filled buprenorphine prescription for participants entering the study not taking medication for OUD; cumulative days of prescribed buprenorphine for participants entering the study while not taking methadone, obtained from the state Prescription Drug Program; and Patient Health Questionnaire-9 and PTSD Checklist for DSM-5 scores from participant surveys. Secondary outcomes included days of opioid and other drug use, the Patient-Reported Outcomes Measurement Information System's substance use short form, and the Veterans RAND 12-item health survey. RESULTS: Of 2396 participants assessed for eligibility, 797 were randomized (397 to EUC; 400 to intervention); 433 (54.3%) were female and 364 (45.7%) male, with a mean (SD) age of 40.2 (11.9) years. Six-month survey retention was 68% for EUC and 64% for collaborative care. Adjusted mean (SD) differences on primary outcomes for collaborative care vs EUC were: 7.0 (95% CI, -3.4 to 17.4; P = .19) for days until first buprenorphine prescription; 4.3 (95% CI, -7.4 to 16.0; P = .47) for cumulative days of prescribed buprenorphine; -1.0 (95% CI, -2.3 to 0.3; P = .13) for Patient Health Questionnaire-9 score; and -0.9 (95% CI, -4.6 to 2.8; P = .63) for PTSD Checklist for the DSM-5 score; none were statistically significant. There were also no observed differences between groups for any secondary or exploratory outcomes; both groups improved over baseline. As-treated exploratory analyses showed evidence for improvements in OUD outcomes in the as-treated population. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that among participants with OUD co-occurring with depression and/or PTSD, collaborative care did not demonstrate evidence of greater improvements in outcomes compared with EUC. Explanations include a possible spillover effect, spontaneous improvement, or the fit of collaborative care for clinically complex patients and settings with few behavioral health practitioners. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04559893 and NCT04634279.

IMPORTANCE: The criterion-standard treatment for opioid use disorder (OUD) is medications for OUD (MOUD). However, less than a quarter of people with OUD receive MOUD. The collaborative care model (CCM) is an evidence-based practice that integrates mental and physical health treatment in primary care settings. Expanding CCM to include patients with OUD could improve MOUD initiation. OBJECTIVE: To compare the effectiveness of CCM for OUD and co-occurring mental health symptoms (intervention) with CCM for mental health symptoms only (active control). DESIGN, SETTING, AND PARTICIPANTS: This hybrid type 2a trial cluster-randomized 24 US primary care clinics to intervention or control. Participants included patients with OUD and mental health symptoms who were not receiving specialty mental health care or specialty substance use treatment. Study data were analyzed from February 2024 to January 2025. INTERVENTIONS: The control care team included primary care practitioners, care managers, and psychiatric consultants. Primary care practitioners prescribed psychotropic medications with psychiatric consultation. Care manager activities included patient education, engagement and self-management, shared decision-making, measurement-based care for mental health symptoms, and brief psychotherapy for mental health. The intervention had the same components as the control, with additional MOUD training and psychiatric consultation for primary care practitioners, measurement-based care for OUD, and brief psychotherapy for OUD. MAIN OUTCOMES AND MEASURES: Participants completed research assessments at baseline, 3 months, and 6 months. The multiple primary outcomes were past-month number of days of using opioids and the Veterans RAND 12 Mental Health Component Summary score. RESULTS: A total of 254 patients (mean [SD] age, 40.9 [12.4] years; 139 women [59.9%]) participated in the trial. Most participants (172 of 212 [81.1%]) were taking MOUD at baseline. Days using opioids decreased in both the control and intervention groups. The intervention significantly reduced opioid use more than the control with a medium effect size (adjusted ratio of odds ratio, 0.10; 95% CI, 0.03-0.38; Cohen d = -0.44; P < .001). Mental Health Component Summary scores improved slightly in both the control and intervention groups. The intervention did not significantly improve scores more than control (adjusted difference in change, -1.20; 95% CI, -4.97 to 2.57; Cohen d = -0.09; P = .53). CONCLUSIONS AND RELEVANCE: Findings of this cluster randomized clinical trial indicate that OUD can be successfully managed in primary care with CCM, especially CCM for OUD and mental health symptoms. Primary care clinics with MOUD prescribers should consider implementing CCM for OUD and mental health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04600414.

Untreated peripartum psychiatric illness is a major public health concern, with significant effects for both pregnant women and their infants. Despite high levels of need, barriers to care continue to obstruct access for women in the preconception, pregnant, and postpartum periods. Evidence from randomized controlled trials suggests that perinatal collaborative care service models can improve access and reduce mental health burden for peripartum women with posttraumatic stress and depression. However, the literature describing the implementation of such programs outside of formal clinical trials is sparse. Here, we report on our service model at the Maternal Outpatient Mental Health Services (MOMS) clinic, a collaborative care clinic within the Obstetrics and Gynecology department. We describe how we implement the core, evidence-based pillars of our model, including (1) integration into primary care, (2) coordinated care support, (3) attention to the parent-infant relationship, (4) trauma-informed care, and (5) measurement-based care. We report on descriptive data at intake from 204 pregnant and postpartum women who presented to our clinic between August 2023 and June 2024. We conclude with a reflection on the successes and challenges of this model as well as a discussion about future directions for the clinic.

Perinatal mood and anxiety disorders (PMADs) are the most common complication of pregnancy, affecting 600,000 to 900,000 birthing people in the United States annually. Less-than-optimal outcomes necessitates innovations in care delivery to better meet the needs of birthing people. The perinatal Collaborative Care Model (pCCM) represents one promising approach to improving patient outcomes. The pCCM includes a Care Manager, patient registry, and weekly clinical huddles, collectively designed to reflect the committment to ensuring all patients referred to the pCCM achieve remission of their mental health symptoms. While CCMs show great success in Primary Care settings, research on their efficacy in obstetric clinics is limited. In addition, while the CCM is an acceptable and accessible model of care, community based participatory research practices can optimize these implementation outcomes by centering the voices of the community the program intends to serve. Community engagement has led to the creation of an adapted version of the pCCM, COMPASS PLUS (Collaborative Care Model for Perinatal Wellness Support Services - Population Level Equity-Centered Systems Change). Herein, we describe the design of a stepped wedge randomized trial with an effectiveness-implementation design to assess the effectiveness of COMPASS+ and evaluate implementation strategies for the COMPASS+ model.