Acceptance and Commitment Therapy for Chronic Pain in SCI: Development and Testing of an eHealth Program
NCT ID: NCT06098170
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2023-11-15
2024-07-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Unguided use of the My SCI Toolkit program
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.
Coached My SCI Toolkit
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.
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.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Significant cognitive impairment as indicated by scores ≥2 on cognitive screener
18 Years
ALL
No
Sponsors
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The Craig H. Neilsen Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Anna Kratz
Professor of Physical Medicine and Rehabilitation
Principal Investigators
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Anna Kratz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HUM00192610
Identifier Type: -
Identifier Source: org_study_id
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