NCT05527691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

August 31, 2022

Last Update Submit

February 12, 2025

Conditions

Spinal Cord InjuriesRelationship, Marital

Keywords

spinal cord injuriescouplerelationshipresilience

Outcome Measures

Primary Outcomes (16)

  • 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)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

SupportGroove

EXPERIMENTAL

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.

Behavioral: SupportGroove

Waitlist control

NO INTERVENTION

Participants will be waitlisted for 8 weeks.

Interventions

SupportGrooveBEHAVIORAL

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.

SupportGroove

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

McGuire Research Institute

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Alexandra L Terrill, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Occupational Recreational Therapy

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

October 3, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)