Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Unguided use of the My SCI Toolkit program
* Behavioral: Coached My SCI Toolkit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unguided use of the My SCI Toolkit program<br> | Behavioral: Unguided use of the My SCI Toolkit program<br>* 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.<br>|
| Experimental: Coached My SCI Toolkit<br> | Behavioral: Coached My SCI Toolkit<br>* 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.<br>|
| No Intervention: Wait-list control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 8 weeks (post intervention) | 
| Patient Global Impression of Change (PGIC) | This is a one question scale that participants select from no change (1) to a great deal better (7). | 8 weeks (post intervention) | 
| Change in SCI-QOL Pain Interference Short Form | 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. | Baseline, 8 weeks (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form | 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. | Baseline, 8 weeks (post intervention) | 
| Change in SCI-QOL Pain Behavior Short Form | 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. | Baseline, 8 weeks (post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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My SCI Toolkit, eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention, Chronic pain