Assessment and Treatment for Chronic Pain in Veterans With Serious Mental Illness

Phase

N/A

Condition

Affective Disorders

Tourette's Syndrome

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

Cognitive Behavioral Therapy for Chronic Pain

Health and Wellness

Clinical Study ID

NCT04118283

D3069-W

1IK2RX003069-01A2

Ages > 18
All Genders

Study Summary

Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Have a chronic musculoskeletal pain diagnosis
Have a Defense and Veterans Pain Rating Scale (DVPRS) rating of 4 or greater forpain severity
Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolardisorder) per medical record
18 years of age or older
Enrolled in outpatient programming within the VA Maryland Health Care System at timeof consent/study reenrollment
Have regular access to a telephone
Capacity to sign informed consent

Exclusion

Exclusion Criteria:

Are engaging in moderate-to-severe substance use that would impact their ability toparticipate and/or would require a higher level of care (as determined by treatingprovider)
Engagement in Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), whethercurrently or in the past
Have a current acute pain condition or limited mobility (i.e., unable to walk onecity block) that would interfere with their ability to engage in CBT-CPinterventions (e.g., activity pacing/walking program)

Study Design

Cognitive Behavioral Therapy for Chronic Pain

March 18, 2021

August 29, 2025

Study Description

This research study will address critical gaps in our understanding and management of chronic musculoskeletal pain in Veterans with serious mental illness (SMI), addressing the following aims:

Aim 1: Complete a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of CBT-CP and preliminarily evaluate participant responses to intervention.

Aim 1a (Primary): Determine feasibility by demonstrating adequate rates of recruitment and completion of and fidelity to the CBT-CP intervention as well as quality and acceptability of chosen assessments.

Aim 1b (Primary): Determine acceptability by obtaining favorable ratings from satisfaction questionnaires and interviews.

Aim 1c (Exploratory): Preliminarily evaluate participant responses to intervention by exploring changes in functioning and quality of life among Veterans randomized to the CBT-CP condition (n=30).

Aim 2: Determine the feasibility of collecting EMA data to examine the temporal relationships among mental health symptoms, pain severity, and health-related functioning. Data will be collected at baseline from the 45 Veterans in the Aim 1 RCT.

Aim 2b (Primary): Determine feasibility of this approach through adherence to the EMA call schedule and overall response rates.

Aim 2a (Exploratory): Explore relationships among mental health symptoms, pain severity, and health-related functioning captured in real time.

Aim 3: Complete a well-specified process evaluation to explore how to optimize CBT-CP for use in Veterans with SMI and chronic musculoskeletal pain in future clinical trials. This evaluation will integrate qualitative data from 15 interviews with Veterans in the CBT-CP condition, CBT-CP interventionist notes, and quantitative data from Aims 1 and 2.

Connect with a study center

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland 21201
United States
Site Not Available
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore 4347778, Maryland 4361885 21201
United States
Site Not Available

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