- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05527691
Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping with Spinal Cord Injury
February 12, 2025 updated by: Alexandra Terrill, University of Utah
The purpose of this study is to test the preliminary effects of an 8-week mobile application-based program (SupportGroove) developed for persons with spinal cord injury and their romantic partners.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eligible couples who provide informed consent will be enrolled in the study and will be randomized to either immediately start the 8-week SupportGroove program or be waitlisted for 8-weeks before starting the program.
While actively participating in the program, couples will use the app to engage in daily "quests" (positive psychology-based activities to be completed on their own or as a couple).
Both partners in the participating couple complete self-report assessments at baseline (0 weeks), 8 weeks, 16 weeks, and 28 weeks.
Study Type
Interventional
Enrollment (Actual)
168
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- University of Utah
-
-
Virginia
-
Richmond, Virginia, United States, 23249
- McGuire Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- cohabitating romantic couples where one partner has sustained a spinal cord injury at least 3 months prior to enrolling in the study
- be able to read and understand printed English instructions
- have a smartphone, tablet, or personal computer with internet access
Exclusion Criteria:
- the partner has a spinal cord injury or other major neurological condition
- either partner is unable to read and understand printed English instructions
- either partner does not consent to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SupportGroove
8-week intervention that is remotely delivered through a mobile app, consisting of daily "quests" (positive psychology-based activities) completed individually and as a couple.
|
An app-delivered program consisting of positive psychology-based activities, such as expressing gratitude, finding meaning, savoring, and fostering connections.
Participants complete daily "quests" suggested through the app, some of which are completed on their own, and some with their partner.
|
|
No Intervention: Waitlist control
Participants will be waitlisted for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Time Frame: Baseline (0 weeks)
|
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
|
Baseline (0 weeks)
|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Time Frame: 8 weeks
|
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
|
8 weeks
|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Time Frame: 16 weeks
|
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
|
16 weeks
|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Time Frame: 28 weeks
|
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
|
28 weeks
|
|
Patient Health Questionnaire-9
Time Frame: 0 weeks
|
9-item depression measure; rated from 0-3 (not at all-nearly every day); score range from 0-27, higher scores = more depressed /worse outcome
|
0 weeks
|
|
Patient Health Questionnaire-9
Time Frame: 8 weeks
|
9-item depression measure; rated from 0-3 (not at all-nearly every day); score range from 0-27, higher scores = more depressed /worse outcome
|
8 weeks
|
|
Patient Health Questionnaire-9
Time Frame: 16 weeks
|
9-item depression measure; rated from 0-3 (not at all-nearly every day); score range from 0-27, higher scores = more depressed /worse outcome
|
16 weeks
|
|
Patient Health Questionnaire-9
Time Frame: 28 weeks
|
9-item depression measure; rated from 0-3 (not at all-nearly every day); score range from 0-27, higher scores = more depressed /worse outcome
|
28 weeks
|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Time Frame: 0 weeks
|
10-items assessing aspects of well-being; rated from 1-5 (never-always); score range from 10-50, higher score = greater well-being /better outcome
|
0 weeks
|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Time Frame: 8 weeks
|
10-items assessing aspects of well-being; rated from 1-5 (never-always); score range from 10-50, higher score = greater well-being /better outcome
|
8 weeks
|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Time Frame: 16 weeks
|
10-items assessing aspects of well-being; rated from 1-5 (never-always); score range from 10-50, higher score = greater well-being /better outcome
|
16 weeks
|
|
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Time Frame: 28 weeks
|
10-items assessing aspects of well-being; rated from 1-5 (never-always); score range from 10-50, higher score = greater well-being /better outcome
|
28 weeks
|
|
Revised Dyadic Adjustment Scale
Time Frame: 0 weeks
|
14-items assessing couple satisfaction and how each partner within the couple perceives their relationship; rated on a scale from 0-5; score range from 0-70, higher scores = better adjustment/greater relationship satisfaction /better outcome
|
0 weeks
|
|
Revised Dyadic Adjustment Scale
Time Frame: 8 weeks
|
14-items assessing couple satisfaction and how each partner within the couple perceives their relationship; rated on a scale from 0-5; score range from 0-70, higher scores = better adjustment/greater relationship satisfaction /better outcome
|
8 weeks
|
|
Revised Dyadic Adjustment Scale
Time Frame: 16 weeks
|
14-items assessing couple satisfaction and how each partner within the couple perceives their relationship; rated on a scale from 0-5; score range from 0-70, higher scores = better adjustment/greater relationship satisfaction /better outcome
|
16 weeks
|
|
Revised Dyadic Adjustment Scale
Time Frame: 28 weeks
|
14-items assessing couple satisfaction and how each partner within the couple perceives their relationship; rated on a scale from 0-5; score range from 0-70, higher scores = better adjustment/greater relationship satisfaction /better outcome
|
28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexandra L Terrill, PhD, University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2022
Primary Completion (Actual)
December 30, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
August 31, 2022
First Submitted That Met QC Criteria
August 31, 2022
First Posted (Actual)
September 2, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 12, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 720484
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.