Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial

BACKGROUND: Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies. OBJECTIVE: Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression. DESIGN: 9-week single-blind randomized control trial with a 12-week maintenance phase (intervention—medical groups; control—primary care provider visit) SETTING: Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers. PARTICIPANTS: 159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms. INTERVENTIONS: IMGV intervention– 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks. MEASUREMENTS: Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization. RESULTS: There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18–0.98) compared to controls. LIMITATIONS: Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV. CONCLUSION: Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group. TRIAL REGISTRATION: clinicaltrials.gov NCT02262377.