Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT06098170
- Lead Sponsor
- University of Michigan
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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
- Currently in inpatient care or intensive outpatient physical therapy
- Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in SCI-QOL Pain Interference Short Form 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 8 weeks Percent of participants in each arm that dropped out of the study 8 weeks Number of minutes/week spent on the My SCI Toolkit website 8 weeks Participant Satisfaction Evaluation 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) 8 weeks (post intervention) This is a one question scale that participants select from no change (1) to a great deal better (7).
- Secondary Outcome Measures
Name Time Method Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form Baseline, 8 weeks (post intervention) This is a 3-question survey that is scored on a T-score metric with Mean=50, Standard Deviation=10. A higher score means higher pain intensity.
Change in SCI-QOL Pain Behavior Short Form Baseline, 8 weeks (post intervention) This survey has 7-questions. Three questions are answered never (1) to always (5) and 3 questions are answered had no pain (1) to always (6). Scores are on a T-score metric with a Mean=50, Standard Deviation=10. A higher score indicates more behavioral manifestations of pain.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Michigan🇺🇸Ann Arbor, Michigan, United States