The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Recruitment Feasibility (Ability)
研究概览
简要总结
The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program compared to a health education program for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.
详细描述
The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program (GetActive-Fitbit) compared to a health education program (Healthy Living for Pain) for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.
Each program will consist of ten 60-minute sessions in-person. Participants will receive a treatment manual and ActiGraph watch to assess physical function. There are 3 assessment points consisting of self-report surveys and performance-based measures: baseline, post-program, and 6-month follow-up. All participants will receive access to the other program's manual and website after completing the six-month follow-up.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female outpatients, age 18 years or older
- •Fluent in English
- •Have nonmalignant chronic musculoskeletal pain for more than 3 months
- •Able to perform a 6-minute walk test (6MWT)
- •Owns a smartphone with Bluetooth 4.0 or computer
- •Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol.
- •Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
- •Low-level of activity (must meet 2/3 criteria; if difficult to assess, recruiter may ask participant to report their recent step data from their smartphone to better understand their activity level)
- •Sitting for more than 8 hours/day per self-report
- •Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report
- •Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report
排除标准
- •Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
- •Serious mental illness or instability for which hospitalization may be likely in the next 6 months
- •Current active suicidal ideation reported on self-report
- •Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder
- •Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months
- •Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >45 min 3 times/week within the last 3 months or less.
- •Regular use of Fitbit DMD in the last 3 months
- •Unable to walk/in a wheelchair
- •Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).
研究组 & 干预措施
GetActive-Fitbit
GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking.
干预措施: GetActive-Fitbit (Behavioral)
Healthy Living for Pain
Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling.
干预措施: Healthy Living for Pain (Behavioral)
结局指标
主要结局
Recruitment Feasibility (Ability)
时间窗: 1 Year
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Recruitment Feasibility (Timeliness) - Number of Participants Recruited in 1 Year
时间窗: 1 Year
Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year. Participants will be considered enrolled upon randomization. Assessed by the number of participants enrolled in the study over the course of 1 year. If number enrolled meets or exceeds goal of 90 participants, the benchmark is considered met.
Feasibility of Recruitment Racial and Ethnic Minorities
时间窗: 1 Year
38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.
Intervention Feasibility/ Adherence to Sessions
时间窗: Post-Test (10 Weeks)
≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Credibility and Expectancy Scale - Credibility
时间窗: Baseline (0 Weeks)
≥80 chronic pain patients with credibility scores higher than the Credibility and Expectancy Scale credibility subscale's mid-point, indicating intervention credibility. Credibility subscale scores range from 3 to 27. Higher scores indicate higher perceived credibility for the program.
Client Satisfaction Scale
时间窗: Post-Test (10 Weeks)
≥80 chronic pain patients with satisfaction scores higher than the scale's mid-point, indicating intervention satisfaction.
Retention
时间窗: Post-test (10 weeks), Follow-up (24 weeks)
≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).
Assessment Feasibility
时间窗: 1 Year
We calculated the proportion of assessment procedures that were administered as intended in the the checklists of the study protocol. The number of assessment procedures that were administered in line with the study's protocol checklists was divided by the total number of assessment procedures. The benchmark was set to 90%, i.e., assessment procedures were deemed feasible if ≥90% of assessment procedures were delivered as specified in the protocol.
Credibility and Expectancy Questionnaire - Expectancy
时间窗: Baseline (0 weeks)
≥80 chronic pain patients with expectancy scores higher than the subscale's mid-point, indicating intervention expectancy. Expectancy subscale scores range from 3 to 27. Higher scores indicate more belief that treatment will help.
次要结局
- 6 Minute Walk Test (6MWT)(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- ActiGraph GT9X(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- PROMIS Depression v1.08b(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- PROMIS Anxiety v1.08a(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- Pain Catastrophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- Pain, Enjoyment of Life and General Activity (PEG-3) Scale(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- WHO Disability Assessment Schedule 2.0 (WHODAS)(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- Tampa Kinesiophobia Scale (TSK)(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- Measure of Current Status (MOCS)(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- Cognitive and Affective Mindfulness Scale (CAMS)(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
- Modified Global Impression of Change (MGIC)(Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks))
研究者
Ana-Maria Vranceanu, PhD
Principal Investigator
Massachusetts General Hospital