Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University of Michigan
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Change in SCI-QOL Pain Interference Short Form
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Anna Kratz
Professor of Physical Medicine and Rehabilitation
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Currently in inpatient care or intensive outpatient physical therapy
- •Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
Outcomes
Primary Outcomes
Change in SCI-QOL Pain Interference Short Form
Time Frame: 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
Time Frame: 8 weeks
Percent of participants in each arm that dropped out of the study
Time Frame: 8 weeks
Number of minutes/week spent on the My SCI Toolkit website
Time Frame: 8 weeks
Participant Satisfaction Evaluation
Time Frame: 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)
Time Frame: 8 weeks (post intervention)
This is a one question scale that participants select from no change (1) to a great deal better (7).
Secondary Outcomes
- 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))