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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06098170
• Other study ID #: HUM00192610
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 73
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants in each arm that dropped out of the study		8 weeks
Primary	Number of days/week that My SCI Toolkit was accessed		8 weeks
Primary	Number of minutes/week spent on the My SCI Toolkit website		8 weeks
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)