Clinical trial NCT05527691: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Relationship, Marital
Keywords: spinal cord injuries
couple
relationship
resilience
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: McGuire Research Institute
First posted: 2022-09-02
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
timeFrame: Baseline (0 weeks)
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
timeFrame: 8 weeks
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
timeFrame: 16 weeks
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form
timeFrame: 28 weeks
measure: Patient Health Questionnaire-9
timeFrame: 0 weeks
measure: Patient Health Questionnaire-9
timeFrame: 8 weeks
measure: Patient Health Questionnaire-9
timeFrame: 16 weeks
measure: Patient Health Questionnaire-9
timeFrame: 28 weeks
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
timeFrame: 0 weeks
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
timeFrame: 8 weeks
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
timeFrame: 16 weeks
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Positive Affect and Wellbeing
timeFrame: 28 weeks
measure: Revised Dyadic Adjustment Scale
timeFrame: 0 weeks
measure: Revised Dyadic Adjustment Scale
timeFrame: 8 weeks
measure: Revised Dyadic Adjustment Scale
timeFrame: 16 weeks
measure: Revised Dyadic Adjustment Scale
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: McGuire Research Institute
state: Virginia
Study officials:
affiliation: University of Utah
name: Alexandra L Terrill, PhD
role: PRINCIPAL_INVESTIGATOR
References: