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

NCT04118283 | Completed

• 2 other identifiers: D3069-W1IK2RX003069-01A2
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Affective Disorders, Psychotic

Keywords

Veterans; chronic pain; psychotic disorders; affective disorders, psychotic; cognitive behavioral therapy; ecological momentary assessment

Outcome Measures

Primary Outcomes (3)

• Participant Satisfaction Questionnaire (CSQ-8)

  The CSQ-8 contains eight Likert scale items that ask about quality of service received and if services have been helpful. Scores on the CSQ-8 range from 8 (lowest) to 32 (highest). This measure will be used to assess CBT-CP acceptability (Aim 1b).

  Participants will be assessed following completion of the study intervention, an expected average of 10 weeks

• Service Satisfaction Scale (SSS-30)

  The SSS-30 has 30 items that assess practitioner manner and skill, perceived outcome, office procedures, and accessibility. An overall score ranges from 30 (lowest) to 150 (highest). This measure will be used to assess CBT-CP acceptability (Aim 1b).

  Participants will be assessed following completion of the study intervention, an expected average of 10 weeks

• Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility

  To examine feasibility, engagement and participation in CBT-CP will be tracked across four key objectives: 1) evaluation of recruitment and suitability of eligibility criteria (# consented divided by # approached; # randomized divided by # consented); 2) retention and adherence rates based on the percent who engaged in treatment (% of randomized who attend first 3 sessions) and mean number of sessions attended and treatment dropout percentages (# who dropped out prior to completing treatment divided by # who engaged); 3) outreach efforts (mean number of reminders and outreach contacts made for each participant); and 4) the mean (and SD) number of completed CBT-CP homework assignments, assessed weekly by CBT-CP interventionists.

  Data will be gathered from each participant through intervention completion, an average of 10 weeks

Secondary Outcomes (8)

• West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference

  Participants will be assessed following completion of the study intervention, an expected average of 10 weeks

• Veterans RAND 36-item Health Survey (VR-36)

  Participants will be assessed following completion of the study intervention, an expected average of 10 weeks

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Participants will be assessed following completion of the study intervention, an expected average of 10 weeks

• World Health Organization Quality of Life Scale (WHOQOL-BREF)

  Participants will be assessed following completion of the study intervention, an expected average of 10 weeks

• West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference

  Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.

Study Arms (2)

Cognitive Behavioral Therapy for Chronic Pain

EXPERIMENTAL

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: Cognitive Behavioral Therapy for Chronic Pain

Health and Wellness

ACTIVE COMPARATOR

Health \& Wellness 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.

Behavioral: Health and Wellness

Interventions

Cognitive Behavioral Therapy for Chronic Pain BEHAVIORAL

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.

Also known as: CBT-CP

Cognitive Behavioral Therapy for Chronic Pain

Health and Wellness BEHAVIORAL

Health \& Wellness 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.

Also known as: H&W

Health and Wellness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Maryland Health Care System: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Chronic Pain; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Affective Disorders, Psychotic

Interventions

Cognitive Behavioral Therapy; Health

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics

Study Officials

• Letitia Travaglini, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be collected by experienced Research Assistants (Ras) who will receive in-person training on each assessment measure. All RAs involved in the research study will conduct baseline assessments. One RA will remain blind to study condition in order to complete post-treatment and follow-up assessments. A back-up RA supplied by the VISN 5 MIRECC will be trained to conduct assessments in case the blind assessor is unblinded or in need of assistance. If the study condition becomes known, the blind assessor will stop the assessment and either the back-up RA or study PI will finish the assessment(s).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This study involves a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) and preliminarily evaluate participant responses to intervention. The first 45 Veterans who pass screening will be enrolled and randomized to study condition on a rolling basis. Participants will be randomly assigned at a 2:1 ratio to CBT-CP:Health \& Wellness using permuted block randomization with randomly varying block sizes. Veterans will be randomly assigned to either CBT-CP (n = 30) or a manualized Health \& Wellness active control intervention (n = 15). Using an intent-to-treat framework, data will be collected from every participant during the one-week Ecological Momentary Assessment period (prior to RCT baseline assessment) and at baseline, post-treatment, and 3-month follow-up regardless of attendance in their assigned condition.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: March 18, 2021
• Primary Completion: July 4, 2025
• Study Completion: August 29, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)