A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial

Abstract

Background: Chronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy.

Objective: To determine the effectiveness of a group-based CBT intervention for chronic pain.

Design: Pragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592).

Setting: Kaiser Permanente health care systems in Georgia, Hawaii, and the Northwest.

Participants: Adults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy.

Intervention: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care.

Measurements: Self-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes.

Results: A total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups.

Limitation: The inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear.

Conclusion: Primary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication.

Primary funding source: National Institutes of Health.

Appendix Figure.

Study flow diagram. EHR = electronic health record; PCP = primary care provider; PPACT = Pain Program for Active Coping and Training. * Patients could decline to participate at any point in the screening process, including before the telephone eligibility interview; therefore, participants who declined to participate were not necessarily eligible. † Too physically impaired to attend or unavailable because of condition (e.g., hospitalization or dialysis) or planned medical procedure (e.g., surgery).

Figure.

Estimated mean PEGS score, by treatment group and time point, from piecewise linear mixed model. CBT = cognitive behavioral therapy; PEGS = pain intensity and interference with enjoyment of life, general activity, and sleep.