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Exploring the Efficacy of Cognitive Behavioral Therapy for Chronic Pain in Veterans With Serious Mental Illness
Chronic musculoskeletal pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic musculoskeletal pain leads to poorer mental and physical health-related functioning, representing a critical obstacle to rehabilitation and recovery for SMI Veterans. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to evaluate nonpharmacological pain management strategies in this population. This study aims to address this research and clinical gap by testing the efficacy of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI and chronic low back pain. The study will primarily evaluate the impact of CBT-CP on pain-related functioning, quality of life, and pain severity. This study will also examine relationships between pain and mental health symptoms, and how these relationships may change with CBT-CP completion.
Project Background: Chronic musculoskeletal pain is one of the most common physical health diagnoses among individuals with SMI. Individuals with SMI and chronic musculoskeletal pain report worse mental and physical health functioning relative to people with other mental or physical health conditions. Despite knowing about high rates of chronic musculoskeletal pain among individuals with SMI; little research has been conducted to further understand the complex relation between pain and psychiatric symptoms and consider the usefulness or appropriateness of current treatment approaches. What is known is problematic: Veterans with SMI are largely not provided options for nonpharmacological pain management strategies, including CBT-CP, and are more likely to be prescribed pain medications that pose unique risks to this population. Project Objectives: The proposed Merit research will address research and clinical gaps by testing the efficacy of CBT-CP in Veterans with SMI and chronic musculoskeletal pain, notably chronic low back pain. The investigators will complete a large, randomized controlled trial with 190 Veterans, comparing CBT-CP to an active control condition ("Health \& Wellness"). The investigators will examine effects of treatment on functioning and pain interference, quality of life, and pain severity. The investigators will evaluate these variables at baseline, post-treatment, and six months post-treatment through both standardized assessment procedures and timepoints; as well as a one-week ecological momentary assessment (EMA) period prior to each assessment timepoint. The EMA data will allow us to examine inter- and intra-variability in pain and related functioning, including its relationship to SMI symptoms, and to evaluate how engagement in CBT-CP may affect pain variability and its relationship to mental health. Project Methods: This project will include completing a randomized control trial (RCT) with 190 Veteran participants, evaluating impact of CBT-CP versus Health \& Wellness on pain-related functioning and interference, quality of life, and pain severity. The investigators will also explore process variables, including physical activity and pain catastrophizing, as well as moderators, including SMI diagnosis and symptom severity along with pain severity at baseline, to see how these variables affect treatment engagement and outcomes.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States
Start Date
February 1, 2026
Primary Completion Date
September 30, 2029
Completion Date
September 30, 2029
Last Updated
February 9, 2026
190
ESTIMATED participants
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
BEHAVIORAL
Health & Wellness (H&W)
BEHAVIORAL
Lead Sponsor
VA Office of Research and Development
NCT07455929
NCT07460453
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06740383