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

Anne Malaktaris, Niloofar Afari, Pollyanna Casmar, Matthew S Herbert, Rachel Raver, Julie Kangas, Lin Liu, Fadel Zeidan, Ariel J Lang

Contemporary Clinical Trials Communications June 1, 2026 DOI: 10.1016/j.conctc.2026.101646 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized clinical trial Peer reviewed
Sample size 142
Population Veterans with chronic pain and psychological comorbidity (PTSD and/or depression)
Duration 10-week intervention, with assessments at baseline, weekly during intervention, mid-treatment, posttreatment, 3-month and 6-month follow-up
Topics Depression
Keywords Chronic pain Compassion meditation Posttraumatic stress disorder Randomized clinical trial
Registration NCT04651296
Key findings The study is a protocol; no results are reported. The authors hypothesize that CBCT-CP+ will be associated with larger reductions in pain interference and severity of comorbid psychopathology compared to the control.

Abstract

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).

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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