Health Coaching for Chronic Multi-symptom Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- World Health Organization Disability Assessment Schedule
研究概览
简要总结
The National Academy of Medicine (NAM) labels chronic pain as one of the most extensive health care issues facing our society with "severe impacts on all aspects of the lives of its sufferers."1 Pain predominant chronic multisymptom illness (Pain-CMI, e.g., fibromyalgia) is a particularly debilitating and presumptive service connected condition for Veterans who deployed to the Gulf region. Health coaching is an appealing potential approach to improve the disability of Pain-CMI because it is personalized to the Veteran's unique goals and beliefs about Pain-CMI and it will be widely available as the VA is rolling out health coaching. The goal of this proposal is to understand if health coaching is also efficacious for a complex pain condition, Pain-CMI.
详细描述
Purpose:
Chronic pain is one of the most common healthcare issues that Veterans face; it can be very debilitating as well as difficult to treat. Pain Predominant Chronic Multi-symptom Illness (CMI) (e.g., fibromyalgia) is a particularly debilitating and treatment-resistant chronic pain condition and a presumptive service-connected condition for Veterans who deployed to the Gulf region from 1990-2021 (VA Benefits Administration, 2018). There is an urgent need for evidence-based non-pharmaceutical treatments for chronic pain. This study will explore the efficacy of remote-delivered health coaching intervention aimed at modifying lifestyle factors of diet, exercise, social connections, stress, and sleep. The control condition will be supportive psychotherapy.
Study Aims:
Primary Aim 1: Determine if remote-delivered health coaching reduces (H1a) disability and (H2a) pain impairment as compared to remote-delivered supportive psychotherapy for Veterans with Pain-CMI. The investigators will also assess the improvement in (H1b) disability and (H2b) pain impairment at the 24-month follow-up.
Primary Aim 2: Determine if health coaching results in more frequent clinically significant improvement in (H3) disability (20%) and (H4) pain impairment (1 point) as compared to supportive psychotherapy.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator, assessor, biostatistician
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Population. Participants will consist of 250 Veterans with Pain-CMI
- •CMI meets Kansas City (Steele) definition of CMI
- •reports wide-spread pain rated at least 4 on a 0 to 10 point pain bothersome scale
- •rates their activity limitations at least 3 on a 0 to 10 point scale
排除标准
- •life-threatening condition,
- •severe cognitive impairment
- •psychotic disorder, pregnant
- •plans to become pregnant in the next year
- •suicidal intent
研究组 & 干预措施
Health Coaching
The 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward.
干预措施: Health Coaching (Behavioral)
Supportive Psychotherapy
Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was ." ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers.
干预措施: Supportive Psychotherapy (Behavioral)
结局指标
主要结局
World Health Organization Disability Assessment Schedule
时间窗: follow up (24 week)
World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity and is scored from 0-100 with higher = worse disability.
Brief Pain Inventory
时间窗: follow-up (24 weeks)
Brief Pain Inventory (BPI). We will compare the % who have a 1 point improvement between arms. Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. We will use the 7-item interference scale which is scored on a scale of 0-10 with higher = worse pain interference.
World Health Organization Disability Assessment Schedule
时间窗: Post-treatment (12 weeks)
World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity. Consistent with IMMPACT, our primary outcomes include a general measure of disability (WHO-DAS) and a pain specific measure. A 20% improvement will be considered clinically significant. The WHO-DAS is scored on a scale of 0-100 with higher scores = worse disability.
Brief Pain Inventory
时间窗: post-treatment (12-weeks)
Brief Pain Inventory (BPI). Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. There are 7-items for the pain interference subscale which are scored from 0-10 with higher = worse pain interference.
次要结局
- Patient Health Questionnaire-15(post-treatment (12-weeks))
- Illness Perception Questionnaire-Revised(post-treatment (12-weeks))
- Pain Catastrophizing Scale(post-treatment (12-weeks))
- Brief Pain Inventory(post-treatment (12-weeks))
- Behavioral Response to Illness Questionnaire(post-treatment (12-weeks))
- World Health Organization Disability Assessment Schedule(post-treatment (12-weeks))