Spinal Cord InjuriesNCT06098170
Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
A study testing Unguided use of the My SCI Toolkit program and Coached My SCI Toolkit in people with Spinal Cord Injuries, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Unguided use of the My SCI Toolkit program and Coached My SCI Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 21 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently in inpatient care or intensive outpatient physical therapy
- Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Unguided use of the My SCI Toolkit program, Coached My SCI Toolkit
- Keywords
- My SCI Toolkit, eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention, Chronic pain
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unguided use of the My SCI Toolkit programBehavioural
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.
Coached My SCI ToolkitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Unguided use of the My SCI Toolkit program | Experimental | Not described Receives: Behavioral: Unguided use of the My SCI Toolkit program |
| Coached My SCI Toolkit | Experimental | Not described Receives: Behavioral: Coached My SCI Toolkit |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants in each arm that dropped out of the study
Measured: 8 weeks
Number of days/week that My SCI Toolkit was accessed
Measured: 8 weeks
Number of minutes/week spent on the My SCI Toolkit website
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 8 weeks (post intervention)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 8 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Nov 2023
- Primary completion21 Jul 2024
- Study completion21 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Anna Kratz, University of Michigan
- Investigators
- Anna Kratz, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098170
- Sponsor's protocol ID
- HUM00192610
- Status last verified
- May 2024
- First submitted
- 18 Oct 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41989405
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
- ClinicalTrials.gov ID
- NCT06098170
- Acronym / sponsor ID
- HUM00192610
- Conditions
- Spinal Cord Injuries
- Keywords
- My SCI Toolkit, eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 21 Jul 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unguided use of the My SCI Toolkit program | Experimental | Behavioral: Unguided use of the My SCI Toolkit program |
| Coached My SCI Toolkit | Experimental | Behavioral: Coached My SCI Toolkit |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Currently in inpatient care or intensive outpatient physical therapy
- Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unguided use of the My SCI Toolkit programParticipants 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. | Behavioural | Unguided use of the My SCI Toolkit program |
| Coached My SCI ToolkitParticipants 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. | Behavioural | Coached My SCI Toolkit |
Primary outcome
Percent of participants in each arm that dropped out of the study
Time frame: 8 weeks
Number of days/week that My SCI Toolkit was accessed
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).
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.
2 secondary outcomes
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form
Time frame: Baseline, 8 weeks (post intervention)
Change in SCI-QOL Pain Behavior Short Form
Time frame: Baseline, 8 weeks (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 41989405Kratz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Kratz, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unguided use of the My SCI Toolkit program and Coached My SCI Toolkit in people with Spinal Cord Injuries, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants in each arm that dropped out of the study (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06098170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025; AzTrials last refreshed its copy on 28 Oct 2026.