Feasibility of a Positive Affect Skills Intervention for Reducing Racial Disparities in Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Recruitment as Measured by Rates of Enrollment (Aim 1)
研究概览
简要总结
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention.
The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).
详细描述
Specific Aims:
Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS.
Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities.
For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Access to daily internet
- •≥ 50 years of age
- •Able to read and understand English
- •Physician diagnosis confirmation of FMS AND/OR Score ≥ 13 on the 6-item, self-report fibromyalgia screening tool
- •Report having pain for at least the last three months
排除标准
- •Cognitive impairment
- •Current behavioral treatment for pain
- •Enrolled in another pain study
结局指标
主要结局
Recruitment as Measured by Rates of Enrollment (Aim 1)
时间窗: At baseline
Percent enrolled of total eligible participants.
Retention as Measured by Change in Enrollment
时间窗: At baseline; at week 11 (post-intervention)
Percentage enrolled at baseline that completed the post-intervention assessment.
Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1)
时间窗: At week 11 (post-intervention)
The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) "Would you recommend LARKSPUR to a friend?" and (2) "Would you recommend LARKSPUR to someone else with chronic pain?". Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined.
Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1)
时间窗: At week 11 (post-intervention)
Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program.
次要结局
- Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))
- Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))
- Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))
- Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))
- Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))
- Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))
- Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))
- Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2)(At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention))