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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-18

Study Completion Date

2025-08-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain Schizophrenia Psychotic Disorders Bipolar Disorder Affective Disorders, Psychotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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).

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Chronic Pain

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Health and Wellness

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT-CP H&W

Eligibility Criteria

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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 reenrollment
* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No