Efficacy of Cognitively-based compassion training for Veterans with chronic pain with psychological Comorbidity: Protocol for a randomized clinical trial

Chronic pain with psychological comorbidity, especially posttraumatic stress disorder (PTSD) and/or depression, is a prevalent and costly problem, especially among Veterans. Compassion meditation (CM) is a meditative practice that focuses on developing attentional regulation and the intention to assuage suffering. CM-based approaches show promise in ameliorating physical and mental health problems as well as improving quality of life. The objective of this study, a randomized clinical trial, is to compare the efficacy of Cognitively-Based Compassion Training® for Chronic Pain with Psychological Comorbidity (CBCT-CP+) to Health Education while Living with Pain (H.E.L.P.; health psychoeducation control), among 142 Veterans with chronic pain and psychological comorbidity (PTSD and/or depression). Veterans in both groups will participate in 10 weekly, 90-min virtual group sessions, and will be assessed at baseline (0 weeks), weekly during intervention (weeks 1-10), mid-treatment (between weeks 4 and 5), posttreatment (10 weeks), 3-month and 6-month follow-up. The primary aim is to evaluate the efficacy of CBCT-CP + compared to H.E.L.P. in reducing 1) pain interference (measured with Brief Pain Inventory (BPI)) and 2) severity of comorbid psychopathology (PTSD and/or depression; assessed with the Clinical Global Impression scale (CGI)). We hypothesize that CBCT-CP + will be associated with larger reductions in pain interference and severity of comorbid psychopathology (co-primary outcomes) compared to control. We also hypothesize that CBCT-CP + will be associated with greater improvements in life satisfaction and quality of life (secondary outcomes). If efficacious, CBCT-CP + could be further evaluated via multi-site or hybrid effectiveness trials and, ultimately, could improve treatment outcomes for Veterans with chronic pain (CP) and PTSD and/or depression. This randomized clinical trial is registered at clinicaltrials.gov (ID: NCT04651296).