Clinical Trials Directory

Trials / Completed

CompletedNCT06098170

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
73 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

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

Interventions

TypeNameDescription
BEHAVIORALUnguided 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.
BEHAVIORALCoached 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.

Timeline

Start date
2023-11-15
Primary completion
2024-07-21
Completion
2024-07-21
First posted
2023-10-24
Last updated
2025-06-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06098170. Inclusion in this directory is not an endorsement.