Spinal Cord Injuries
Conditions
Keywords
My SCI Toolkit, eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention, Chronic pain
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.
Interventions
BEHAVIORALUnguided use of the My SCI Toolkit program
Participants will be asked to use the My SCI Toolkit program for 8 weeks (without a coach), following the prompts and guides built into the program.
BEHAVIORALCoached My SCI Toolkit
Participants will be asked to use the My SCI Toolkit program for 8 weeks, following the prompts and guides built into the program. Participants will also have weekly phone calls (the first is about 30-45 minutes, and the rest are about 15 minutes) with a study coach. The coach can help answer questions and tailor the skills more to the participant's goals and needs. The coaching sessions will be audio recording for fidelity purposes.
Sponsors
The Craig H. Neilsen Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be enrolled and randomized 1:1:1 to receive unguided use of the My SCI Toolkit program (number (n)=20), coached My SCI Toolkit (n=20) or wait-list control (n=20; treatment as usual) for an 8-week treatment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Percent of participants in each arm that dropped out of the study | 8 weeks | — |
| Number of days/week that My SCI Toolkit was accessed | 8 weeks | — |
| Number of minutes/week spent on the My SCI Toolkit website | 8 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed