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

June 20, 2025 updated by: Anna Kratz, University of Michigan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of participants in each arm that dropped out of the study
Time Frame: 8 weeks
8 weeks
Number of days/week that My SCI Toolkit was accessed
Time Frame: 8 weeks
8 weeks
Number of minutes/week spent on the My SCI Toolkit website
Time Frame: 8 weeks
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.
8 weeks (post intervention)
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).
8 weeks (post intervention)
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.
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
Time Frame: Baseline, 8 weeks (post intervention)
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
Time Frame: Baseline, 8 weeks (post intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

The Craig H. Neilsen Foundation

Investigators

  • Principal Investigator: Anna Kratz, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

July 21, 2024

Study Completion (Actual)

July 21, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00192610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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