Improving the Assessment and Treatment of Chronic Pain in Veterans With Serious Mental Illness
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- VA Office of Research and Development
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Service Satisfaction Scale (SSS-30)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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).
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.
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).
Secondary Outcomes
- 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.)
- Veterans RAND 36-item Health Survey (VR-36)(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)(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)(Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.)