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

Primary Purpose

Spinal Cord Injuries, Relationship, Marital

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SupportGroove
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring spinal cord injuries, couple, relationship, resilience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • cohabitating romantic couples where one partner has sustained a spinal cord injury between 3 months and 5 years 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

Sites / Locations

  • University of UtahRecruiting
  • McGuire Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SupportGroove

Waitlist control

Arm Description

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.

Participants will be waitlisted for 8 weeks.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2022
Last Updated
February 7, 2023
Sponsor
University of Utah
Collaborators
McGuire Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05527691
Brief Title
Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping With Spinal Cord Injury
Official Title
Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
McGuire Research Institute

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Relationship, Marital
Keywords
spinal cord injuries, couple, relationship, resilience

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SupportGroove
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
Participants will be waitlisted for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
SupportGroove
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Description
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
Time Frame
Baseline (0 weeks)
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Description
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
Time Frame
8 weeks
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Description
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
Time Frame
16 weeks
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
Description
10-items assessing state resilience; rated from 1-5 (never-always); score range from 19-50, higher score = more resilient /better outcome
Time Frame
28 weeks
Title
Patient Health Questionnaire-9
Description
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
Time Frame
0 weeks
Title
Patient Health Questionnaire-9
Description
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
Time Frame
8 weeks
Title
Patient Health Questionnaire-9
Description
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
Time Frame
16 weeks
Title
Patient Health Questionnaire-9
Description
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
Time Frame
28 weeks
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Description
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
Time Frame
0 weeks
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Description
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
Time Frame
8 weeks
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Description
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
Time Frame
16 weeks
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
Description
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
Time Frame
28 weeks
Title
Revised Dyadic Adjustment Scale
Description
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
Time Frame
0 weeks
Title
Revised Dyadic Adjustment Scale
Description
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
Time Frame
8 weeks
Title
Revised Dyadic Adjustment Scale
Description
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
Time Frame
16 weeks
Title
Revised Dyadic Adjustment Scale
Description
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
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra L Terrill, PhD
Phone
8015815951
Email
alex.terrill@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Gardner
Phone
8015851462
Email
megan.gardner@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra L Terrill, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra L Terrill, PhD
Phone
801-581-5951
Email
alex.terrill@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Megan Gardner
Email
uspring@utah.edu
Facility Name
McGuire Research Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott McDonald, PhD
Phone
804-675-5000
Ext
3633

12. IPD Sharing Statement

Plan to Share IPD
No

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

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