Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527691
• Other study ID #: 720484
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: Alexandra L Terrill, PhD
• Phone: 8015815951
• Email: alex.terrill[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Relationship, Marital
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• SupportGroove
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.

Locations

Country	Name	City	State
United States	McGuire Research Institute	Richmond	Virginia
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	McGuire Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form	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)
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form	10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome	8 weeks
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form	10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome	16 weeks
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form	10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome	28 weeks
Primary	Patient Health Questionnaire-9	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
Primary	Patient Health Questionnaire-9	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
Primary	Patient Health Questionnaire-9	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
Primary	Patient Health Questionnaire-9	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
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing	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
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing	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
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing	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
Primary	Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing	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
Primary	Revised Dyadic Adjustment Scale	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
Primary	Revised Dyadic Adjustment Scale	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
Primary	Revised Dyadic Adjustment Scale	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
Primary	Revised Dyadic Adjustment Scale	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