A Randomized Controlled Trial Testing a Skills-Based Program Called "A Toolkit for Optimal Recovery" Delivered Via Secure Live Video Compared to Standard Medical Care in Patients With Acute Musculoskeletal Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Adherence to ToR
研究概览
简要总结
The aims of this study are to test a manualized mind body skills-building program aimed at preventing the development of chronic pain and disability following acute musculoskeletal injury in at-risk patients.
详细描述
This is a pilot randomized feasibility trial of the mind body program Toolkit for Optimal Recovery versus usual medical care. The Toolkit is delivered via secure live video to patients at risk for chronic pain, at 1-2 months after injury. The primary aim of this study is to determine the feasibility and acceptability of the program, randomization, procedures and outcome measures. Secondarily, we report means and standard deviation and explore change in quantitative outcomes in the Toolkit compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Diagnosis of musculoskeletal injury in the past 1-2 months
- •18 years of age or older
- •English fluency and literacy
- •PCS OR, PASS score above median split
排除标准
- •Major medical comorbidity expected to worsen in the next 6 months
- •Comorbid chronic pain condition
- •Antidepressant medication change in the past 6 months
- •Secondary gains such as litigations or workers compensation procedures
- •Diagnosis of psychosis, bipolar disorder or active substance dependence (by self report)
- •Unwilling or unable to use videoconferencing
研究组 & 干预措施
Toolkit for Optimal Recovery after Injury
The Toolkit for Optimal Recovery after Injury (ToR) is a mind body skills based program delivered individually via secure live video. The format is a 4-week program with weekly meetings and a focus on teaching skills to optimize recovery and prevent chronic pain and disability.
干预措施: The Toolkit for Optimal Recovery after Injury (Behavioral)
Usual Care
The Usual Care (UC) group will continue with their current medical care.
结局指标
主要结局
Adherence to ToR
时间窗: 4 weeks.
We will report number of participants who completed at least 3 out of 4 ToR sessions
Satisfaction with ToR
时间窗: 4 weeks; 3 months
3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.
Acceptability
时间窗: 4 weeks; 3 months
We will report number of patients who finished ToR and UC and completed post-test from those who started the study (were randomized); We will also report number of participants who provided 3 months follow up
Adherence to homework
时间窗: 4 weeks
determined by number of homework logs returned
Therapist adherence survey
时间窗: 4 weeks
Items assessing whether the therapist taught each of the skills included in each of the 4 sessions
Feasibility of recruitment
时间窗: 0 Weeks
We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized
Feasibility of outcome measures
时间窗: 0 weeks; 4 weeks; 3 months
We will report number of missing items and calculate reliability of outcome measures
次要结局
- Pain Catastrophizing(0 Weeks, 4 Weeks, 3 Months)
- Post Traumatic Stress Disorder(0 Weeks, 4 Weeks, 3 Months)
- Physical Function(0 Weeks, 4 Weeks, 3 Months)
- Pain Anxiety(0 Weeks, 4 Weeks, 3 Months)
- Pain intensity(0 Weeks, 4 Weeks, 3 Months)
- Depression(0 Weeks, 4 Weeks, 3 Months)
研究者
Ana-Maria Vranceanu, PhD
Clinical Psychologist
Massachusetts General Hospital