Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of minutes/week spent on the My SCI Toolkit website
研究概览
简要总结
This study will test the newly-developed My spinal cord injury (SCI) Toolkit program in two formats - unguided use of the program and use supported by a coach. These two active treatment formats will be compared to treatment as usual (waitlist control) in adults with chronic pain and SCI.
Hypotheses include:
- Treatment adherence, participant satisfaction, and perception of positive change will be high and drop-out rates low for both treatments but will be better in the coached compared to the unguided arm
- In terms of pre- to post-treatment changes in pain interference, coached My SCI Toolkit program will be superior to treatment as usual
详细描述
All participants will also be asked to complete online surveys at baseline (before being randomized to a group), half-way through the 8-week study period, and after the 8-week study period is over. The surveys are online and can be completed from home. Participants in the unguided and coached programs will also be asked to complete a weekly online survey asking about use of the website in the past week, taking approximately 5 minutes to complete.
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
- 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 SCI (all injury levels included);
- •Average pain intensity over the past 3 months greater or equal to (≥) 4/10 on 0-10 numerical rating scale
- •Fluent in English and able to read English at a 6th grade level
- •Access to internet connected device (phone, tablet, computer) and telephone
- •Willingness to maintain stable analgesic regimen during study period
排除标准
- •Currently in inpatient care or intensive outpatient physical therapy
- •Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
研究组 & 干预措施
Unguided use of the My SCI Toolkit program
干预措施: Unguided use of the My SCI Toolkit program (Behavioral)
Coached My SCI Toolkit
干预措施: Coached My SCI Toolkit (Behavioral)
Wait-list control
Participants will not access the My SCI Toolkit program during the 8-week study period and will be asked to continue daily life, including management of pain, as usual.
结局指标
主要结局
Number of minutes/week spent on the My SCI Toolkit website
时间窗: 8 weeks
Change in SCI-QOL Pain Interference Short Form
时间窗: Baseline, 8 weeks (post intervention)
This is a 10-question survey that participants answer from not at all (1) to very much (5). Scores are on a T-score metric with Mean=50, Standard Deviation=10. A higher score means more interference.
Number of days/week that My SCI Toolkit was accessed
时间窗: 8 weeks
Percent of participants in each arm that dropped out of the study
时间窗: 8 weeks
Participant Satisfaction Evaluation
时间窗: 8 weeks (post intervention)
This is a 12-question survey that participants answer with scores ranging from 1-4. The total scores range from 12-48 with a higher score meaning more satisfaction.
Patient Global Impression of Change (PGIC)
时间窗: 8 weeks (post intervention)
This is a one question scale that participants select from no change (1) to a great deal better (7).
次要结局
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form(Baseline, 8 weeks (post intervention))
- Change in SCI-QOL Pain Behavior Short Form(Baseline, 8 weeks (post intervention))
研究者
Anna Kratz
Professor of Physical Medicine and Rehabilitation
University of Michigan