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

Primary Purpose

Spinal Cord Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unguided use of the My SCI Toolkit program
Coached My SCI Toolkit
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring My SCI Toolkit, eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention, Chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Unguided use of the My SCI Toolkit program

Coached My SCI Toolkit

Wait-list control

Arm 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.

Outcomes

Primary Outcome Measures

Percent of participants in each arm that dropped out of the study
Number of days/week that My SCI Toolkit was accessed
Number of minutes/week spent on the My SCI Toolkit website
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.
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).
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.

Secondary Outcome Measures

Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form
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.
Change in SCI-QOL Pain Behavior Short Form
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.

Full Information

First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
University of Michigan
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT06098170
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
My SCI Toolkit, eHealth-delivered Acceptance and Commitment Therapy (ACT) intervention, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unguided use of the My SCI Toolkit program
Arm Type
Experimental
Arm Title
Coached My SCI Toolkit
Arm Type
Experimental
Arm Title
Wait-list control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Unguided use of the My SCI Toolkit program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coached My SCI Toolkit
Intervention Description
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 Outcome Measure Information:
Title
Percent of participants in each arm that dropped out of the study
Time Frame
8 weeks
Title
Number of days/week that My SCI Toolkit was accessed
Time Frame
8 weeks
Title
Number of minutes/week spent on the My SCI Toolkit website
Time Frame
8 weeks
Title
Participant Satisfaction Evaluation
Description
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.
Time Frame
8 weeks (post intervention)
Title
Patient Global Impression of Change (PGIC)
Description
This is a one question scale that participants select from no change (1) to a great deal better (7).
Time Frame
8 weeks (post intervention)
Title
Change in SCI-QOL Pain Interference Short Form
Description
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.
Time Frame
Baseline, 8 weeks (post intervention)
Secondary Outcome Measure Information:
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form
Description
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.
Time Frame
Baseline, 8 weeks (post intervention)
Title
Change in SCI-QOL Pain Behavior Short Form
Description
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.
Time Frame
Baseline, 8 weeks (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristi Pickup
Phone
734-764-4072
Email
knpicku@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Kratz, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristi Pickup, MSW
Phone
734-764-4072
Email
knpicku@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Anna Kratz, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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