Collaborative Care Shows No Added Benefit Over Enhanced Usual Care in OUD with Depression or PTSD: JAMA
USA: A randomized clinical trial published in JAMA Internal Medicine suggests that a collaborative care model adapted for low-resource primary care settings does not provide additional benefit over enhanced usual care for adults with opioid use disorder (OUD) and co-occurring depression and/or posttraumatic stress disorder (PTSD).
The CLARO trial was led by Katherine E. Watkins of RAND, Santa Monica, California, and offers important insights into the real-world application of integrated behavioral health care.
Collaborative care is an established, team-based approach for managing mental health conditions in primary care, typically involving care managers, specialist input, and structured follow-up. Although effective for depression and anxiety, its role in treating OUD alongside serious mental health conditions has been less clear. The CLARO trial sought to determine whether a six-month collaborative care intervention could improve clinical outcomes more than enhanced usual care in this complex patient population.
The pragmatic, single-masked randomized clinical trial was conducted in 18 primary care clinics across California and New Mexico between January 2021 and December 2023. Adult participants with probable OUD and major depression and/or PTSD were randomly assigned to receive either collaborative care or enhanced usual care. In the intervention group, community health workers acted as care managers and worked with primary care clinicians and addiction psychiatrists to deliver evidence-based treatments for OUD, depression, and PTSD, while also addressing biopsychosocial needs and facilitating referrals for psychotherapy.
Of 2,396 individuals assessed for eligibility, 797 participants were randomized, with 400 assigned to collaborative care and 397 to enhanced usual care. The mean age of participants was 40 years, and just over half were women. Six-month follow-up survey retention was similar in both groups. Primary outcomes included time to initiation of buprenorphine, cumulative days of prescribed buprenorphine, and changes in depression and PTSD symptom scores.
The study revealed the following findings:
- At six months, there were no statistically significant differences between the collaborative care and enhanced usual care groups for any primary outcome.
- Outcomes related to buprenorphine initiation and use were similar in both groups.
- Severity of depression and PTSD symptoms did not differ meaningfully between the two care approaches.
- Secondary outcomes, including substance use patterns, patient-reported functioning, and overall health status, were comparable across groups.
- Both groups showed improvement from baseline across multiple clinical outcomes over the follow-up period.
The researchers suggested several possible explanations for these findings. Improvements seen in the enhanced usual care group may reflect spillover effects within clinics, spontaneous symptom improvement over time, or the relatively strong level of usual care provided during the study. Additionally, the authors noted that collaborative care may be less well suited for patients with high clinical complexity, particularly in settings with limited behavioral health resources.
Overall, the CLARO trial indicates that for adults with OUD and co-occurring depression or PTSD, collaborative care did not outperform enhanced usual care. The findings highlight the need for alternative or more tailored care models to effectively address the needs of clinically complex patients in resource-constrained primary care settings.
Reference:
Watkins KE, Osilla KC, McCullough CM, et al. Collaborative Care for Opioid Use Disorder and Mental Illness: The CLARO Randomized Clinical Trial. JAMA Intern Med. Published online December 29, 2025. doi:10.1001/jamainternmed.2025.7036
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