Spinal Cord InjuriesNCT05527691
Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping with Spinal Cord Injury
A study testing SupportGroove in people with Spinal Cord Injuries and Relationship, Marital, run by University of Utah at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Relationship, Marital
- What is being tested?
- SupportGroove
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McGuire Research Institute
Richmond, Virginia, 23249
University of Utah
Salt Lake City, Utah, 84108
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Relationship, Marital
- Being tested
- SupportGroove
- Keywords
- spinal cord injuries, couple, relationship, resilience
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupportGrooveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SupportGroove |
| Waitlist control | No intervention | Participants will be waitlisted for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start3 Oct 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- McGuire Research Institute
- Responsible party
- Principal investigator, Alexandra Terrill, University of Utah
- Investigators
- Alexandra L Terrill, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527691
- Sponsor's protocol ID
- 720484
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2022
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing SupportGroove: a Novel Mhealth Intervention for Couples Coping with Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05527691
- Acronym / sponsor ID
- 720484
- Conditions
- Spinal Cord Injuries, Relationship, Marital
- Keywords
- spinal cord injuries, couple, relationship, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- McGuire Research Institute
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SupportGroove | Experimental | Behavioral: SupportGroove8-week intervention that is remotely delivered through a mobile app, consisting of daily "quests" (positive psychology-based activities) completed individually and as a couple. |
| Waitlist control | No intervention | –Participants will be waitlisted for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SupportGrooveAn 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. | Behavioural | SupportGroove |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra L Terrill, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SupportGroove in people with Spinal Cord Injuries and Relationship, Marital, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Injury Quality of Life (SCI-QOL) Resilience-Short Form (time frame: Baseline (0 weeks)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.