Trial results for a pilot study evaluating a coaching and decision aid intervention for Black patients with comorbid Depression and Chronic Pain were posted on ClinicalTrials.gov on 2025-06-11, showing the intervention group achieved a mean change of -2.36 in PHQ-8 scores at 3 months.

Background

Depression and chronic pain frequently co-occur, presenting significant challenges for patient management and quality of life. This comorbidity is particularly pronounced in underserved populations, including Black patients, who may face additional barriers to accessing effective nonpharmacological pain treatments (NPTs). Addressing these health disparities is a critical public health goal. The NIH Helping to End Addiction Long-term (HEAL) initiative supports projects aimed at improving pain management, reducing reliance on opioids, and promoting health equity. Interventions that empower patients with decision-making tools and support for adherence to NPTs are vital in this context, especially within urban safety-net health systems where resources may be limited.

Trial design

This pilot randomized controlled trial (RCT) was part of a broader 5-year project under the NIH HEAL initiative. The study, which was completed and did not specify a phase, enrolled 30 Black patients with comorbid chronic musculoskeletal pain and depression from primary care within an urban safety-net health system. The trial was a 2-arm study, comparing a "Coaching and Decision Aid" intervention group against a "Control" group. The intervention involved a decision aid and coaching, tailored to Black patients, designed to encourage the use of and adherence to nonpharmacological pain treatments. Primary outcomes were not explicitly listed in the provided data, but key measurements included changes from baseline in the Brief Pain Inventory (BPI) Interference Scale, Patient Health Questionnaire (PHQ)-8, and Generalized Anxiety Disorder Scale (GAD-7).

Key results

The trial reported changes from baseline for several key outcomes at 3 and 6 months:

What this means

The results of this pilot study suggest that a tailored coaching and decision aid intervention may offer a beneficial approach for Black patients experiencing comorbid chronic pain and depression. Across all measured outcomes—pain interference (BPI), depression symptoms (PHQ-8), and anxiety symptoms (GAD-7)—the intervention group consistently demonstrated greater mean reductions from baseline compared to the control group at both 3 and 6 months. For instance, at 3 months, the mean reduction in PHQ-8 scores was -2.36 for the intervention group versus -0.77 for control. Similarly, GAD-7 scores showed a mean reduction of -3.29 in the intervention group compared to -0.08 in the control group at 3 months. These findings indicate the potential of such interventions to improve patient outcomes and encourage engagement with nonpharmacological pain treatments, addressing an important area of health equity. As a pilot study, these initial results warrant further investigation in larger trials to confirm efficacy and generalizability.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05695209, titled "Equity Using Interventions for Pain and Depression - Pilot Study", were posted on 2025-06-11 on clinicaltrials.gov.