CBT-CP for Veterans With SMI

NANot yet recruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

November 15, 2025

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2029

Conditions
Chronic PainSchizophreniaPsychotic DisordersBipolar DisorderAffective Disorders, Psychotic
Interventions
BEHAVIORAL

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan.

BEHAVIORAL

Health & Wellness (H&W)

Health \& Wellness (H\&W) was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area.

Trial Locations (1)

21201

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT06758414 - CBT-CP for Veterans With SMI | Biotech Hunter | Biotech Hunter