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| Name | Class |
|---|---|
| The Craig H. Neilsen Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unguided use of the My SCI Toolkit program | Experimental |
| |
| Coached My SCI Toolkit | Experimental |
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| Wait-list control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unguided use of the My SCI Toolkit program | Behavioral | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Kratz, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41989405 | Derived | Kratz AL, Pickup K, Ginell K, Kuzu D, Waldron-Perrine B, Treder J, Whibley D. Development of an online acceptance and commitment therapy program for pain in spinal cord injury and findings from a randomized pilot trial of coached and unguided delivery formats. Rehabil Psychol. 2026 Apr 16. doi: 10.1037/rep0000670. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2024 | May 1, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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.
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| Coached My SCI Toolkit | Behavioral | 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. |
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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) |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |