Clinical trial NCT06098170: Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
Official title: Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: My SCI Toolkit
eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention
Chronic pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2023-10-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of participants in each arm that dropped out of the study
timeFrame: 8 weeks
measure: Number of days/week that My SCI Toolkit was accessed
timeFrame: 8 weeks
measure: Number of minutes/week spent on the My SCI Toolkit website
timeFrame: 8 weeks
measure: Participant Satisfaction Evaluation
timeFrame: 8 weeks (post intervention)
measure: Patient Global Impression of Change (PGIC)
timeFrame: 8 weeks (post intervention)
measure: Change in SCI-QOL Pain Interference Short Form
timeFrame: Baseline, 8 weeks (post intervention)
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form
timeFrame: Baseline, 8 weeks (post intervention)
measure: Change in SCI-QOL Pain Behavior Short Form
timeFrame: Baseline, 8 weeks (post intervention)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anna Kratz, PhD
role: PRINCIPAL_INVESTIGATOR
References: