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

January 18, 2024 updated by: VA Office of Research and Development

Improving the Assessment and Treatment of Chronic Pain in Veterans With Serious Mental Illness

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Contact:
        • Principal Investigator:
          • Letitia Travaglini, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 18 years of age or older
  • Enrolled in outpatient programming within the VA Maryland Health Care System at time of consent/study renrollment
  • Have regular access to a telephone
  • Capacity to sign informed consent

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy for Chronic Pain
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
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.
Other Names:
  • CBT-CP
Active Comparator: Health and Wellness
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
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.
Other Names:
  • H&W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction Questionnaire (CSQ-8)
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
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)
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
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
Time Frame: Data will be gathered from each participant through intervention completion, an average of 10 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Intereference
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
The West Haven Yale Multidimensional Pain Inventory (WHYMPI) is a 52-item questionnaire providing a comprehensive assessment of components of the chronic pain experience that are helpful for the cognitive-behavioral conceptualization of chronic pain conditions. Each item is rated on a 7-point scale. The interference subscale will be used in this study and measures the impact of pain on functioning (household chores, outdoor work, recreation activities, social activities). An average score is calculated that ranges from 0 (no interference) to 6 (extreme interference). The WHYMPI has been used with a wide range of chronic pain populations and is sensitive to change following rehabilitative interventions. The WHYMPI is used as part of the CBT-CP assessment protocol.
Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
Veterans RAND 36-item Health Survey (VR-36)
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
The Veterans RAND 36-Item Health Survey (VR-36) is a 36-item questionnaire measuring health-related quality of life and 8 domains of health-related functioning (physical functioning, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health). Items are scored on a 3- to 6-point scale and are summed to create each of the domain scores, ranging from 0 (worst health status) to 100 (best health status). The VR-36 demonstrated improved reliability, precision, and validity compared to the SF-36 and among persons with SMI.
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)
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
The WHODAS 2.0 is a 36-item questionnaire assessing health and disability across physical diseases and mental health disorders in both clinical and non-clinical settings and populations. Items are scored on a 5-point scale ranging from 0 (no difficulty) to 4 (extreme difficulty/cannot do) and are summed to create total (ranging from 0 to 144) and domain scores: understanding and communicating (ranging from 0 to 28); Getting around (ranging from 0 to 20); self-care (ranging from 0 to 16); getting along with people (ranging from 0 to 20); life activities (ranging from 0 to 32); and participating in society (ranging from 0 to 32). Higher scores for each domain indicate greater disability. Psychometric properties are excellent, with high internal consistency, test-retest reliability, a stable factor structure, good concurrent validity, and good sensitivity to change.
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)
Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
The World Health Organization Quality of Life Scale (WHOQOL-BREF) is a 26-item questionnaire assessing four domains of quality of life: physical health, psychological well-being, quality of social relationships, and environmental quality. Items use different anchors but are rated on a scale from 1 to 5. Mean scores are calculated for each domain and then transformed to range from 0 (poorest quality of life) to 100 (best quality of life). Psychometric properties of the WHOQOL-BREF are excellent, with demonstrated high internal consistency, discriminant validity, and construct validity for general, mental health, and physical health populations. The WHOQOL-BREF is used as part of the CBT-CP assessment protocol.
Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Intereference
Time Frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
The West Haven Yale Multidimensional Pain Inventory (WHYMPI) is a 52-item questionnaire providing a comprehensive assessment of components of the chronic pain experience that are helpful for the cognitive-behavioral conceptualization of chronic pain conditions. Each item is rated on a 7-point scale. The interference subscale will be used in this study and measures the impact of pain on functioning (household chores, outdoor work, recreation activities, social activities). An average score is calculated that ranges from 0 (no interference) to 6 (extreme interference). The WHYMPI has been used with a wide range of chronic pain populations and is sensitive to change following rehabilitative interventions. The WHYMPI is used as part of the CBT-CP assessment protocol.
Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
Veterans RAND 36-item Health Survey (VR-36)
Time Frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
The Veterans RAND 36-Item Health Survey (VR-36) is a 36-item questionnaire measuring health-related quality of life and 8 domains of health-related functioning (physical functioning, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health). Items are scored on a 3- to 6-point scale and are summed to create each of the domain scores, ranging from 0 (worst health status) to 100 (best health status). The VR-36 demonstrated improved reliability, precision, and validity compared to the SF-36 and among persons with SMI.
Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
The WHODAS 2.0 is a 36-item questionnaire assessing health and disability across physical diseases and mental health disorders in both clinical and non-clinical settings and populations. Items are scored on a 5-point scale ranging from 0 (no difficulty) to 4 (extreme difficulty/cannot do) and are summed to create total (ranging from 0 to 144) and domain scores: understanding and communicating (ranging from 0 to 28); Getting around (ranging from 0 to 20); self-care (ranging from 0 to 16); getting along with people (ranging from 0 to 20); life activities (ranging from 0 to 32); and participating in society (ranging from 0 to 32). Higher scores for each domain indicate greater disability. Psychometric properties are excellent, with high internal consistency, test-retest reliability, a stable factor structure, good concurrent validity, and good sensitivity to change.
Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time Frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
The World Health Organization Quality of Life Scale (WHOQOL-BREF) is a 26-item questionnaire assessing four domains of quality of life: physical health, psychological well-being, quality of social relationships, and environmental quality. Items use different anchors but are rated on a scale from 1 to 5. Mean scores are calculated for each domain and then transformed to range from 0 (poorest quality of life) to 100 (best quality of life). Psychometric properties of the WHOQOL-BREF are excellent, with demonstrated high internal consistency, discriminant validity, and construct validity for general, mental health, and physical health populations. The WHOQOL-BREF is used as part of the CBT-CP assessment protocol.
Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

VA Maryland Health Care System

Investigators

  • Principal Investigator: Letitia Travaglini, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 4, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3069-W
  • 1IK2RX003069-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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