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Completed

NCT Number: NCT06098170

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

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

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Chronic Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Percent of participants in each arm that dropped out of the study

    Time frame: 8 weeks

  2. Number of days/week that My SCI Toolkit was accessed

    Time frame: 8 weeks

  3. Number of minutes/week spent on the My SCI Toolkit website

    Time frame: 8 weeks

  4. 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.

  5. 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).

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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