Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
Study Details
Study Description
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:
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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
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In terms of pre- to post-treatment changes in pain interference, coached My SCI Toolkit program will be superior to treatment as usual
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Unguided use of the My SCI Toolkit program
|
Behavioral: Unguided 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.
|
| Experimental: Coached My SCI Toolkit
|
Behavioral: Coached 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.
|
| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- 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]
- 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).
- 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.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of SCI (all injury levels included);
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Average pain intensity over the past 3 months greater or equal to (≥) 4/10 on 0-10 numerical rating scale
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Fluent in English and able to read English at a 6th grade level
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Access to internet connected device (phone, tablet, computer) and telephone
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Willingness to maintain stable analgesic regimen during study period
Exclusion Criteria:
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Currently in inpatient care or intensive outpatient physical therapy
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Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- The Craig H. Neilsen Foundation
Investigators
- Principal Investigator: Anna Kratz, PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00192610