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

University of Michigan

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Behavioral: Coached My SCI Toolkit; Behavioral: Unguided use of the My SCI Toolkit program

Study type: Interventional

Funder types: Other

Identifiers

NCT06098170

HUM00192610

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 3 patient groups

Unguided use of the My SCI Toolkit program

Experimental group

Treatment:

Behavioral: Unguided use of the My SCI Toolkit program

Coached My SCI Toolkit

Experimental group

Treatment:

Behavioral: Coached My SCI Toolkit

Wait-list control

No Intervention group

Description:

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.