Improving the Assessment and Treatment of Chronic Pain in Veterans With Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Service Satisfaction Scale (SSS-30)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Service Satisfaction Scale (SSS-30)
时间窗: 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
时间窗: 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)
时间窗: 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).
次要结局
- 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.)