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

NCT06098170 | Completed

• 1 other identifier: HUM00192610
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Spinal Cord Injuries

Keywords

My SCI Toolkit; eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention; Chronic pain

Outcome Measures

Primary Outcomes (6)

• Percent of participants in each arm that dropped out of the study

  8 weeks

• Number of days/week that My SCI Toolkit was accessed

  8 weeks

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

  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.

  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).

  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.

  Baseline, 8 weeks (post intervention)

Secondary Outcomes (2)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form

  Baseline, 8 weeks (post intervention)

• Change in SCI-QOL Pain Behavior Short Form

  Baseline, 8 weeks (post intervention)

Study Arms (3)

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.

Interventions

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.

Unguided use of the My SCI Toolkit 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.

Coached My SCI Toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently in inpatient care or intensive outpatient physical therapy
• Significant cognitive impairment as indicated by scores ≥2 on cognitive screener

Sponsors & Collaborators

• University of Michigan: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Kratz, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: November 15, 2023
• Primary Completion: July 21, 2024
• Study Completion: July 21, 2024
• Last Updated: June 26, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)