Clinical Trial of the Online OurRelationship Program for Veteran Couples (NCT05136651) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Trial of the Online OurRelationship Program for Veteran Couples
United States100 participantsStarted 2023-02-06
Plain-language summary
Access to a flexible spectrum of family-based VA mental health care for Veterans is mandated by law. Research shows that relationship distress harms Veterans' mental health, physical health, and mortality, while healthy relationships provide resilience and facilitate recovery from illness. However, there are many barriers to accessing couple and family care within VA, including system-level barriers such as insufficient access to specialty providers and couple-level barriers such as difficulty coordinating schedules and finding childcare. OurRelationship is an evidence-based, coached online intervention for couples that provides flexible, accessible, and scalable treatment to improve relationship functioning. This proposed CDA-2 project will test whether OurRelationship is effective for improving Veterans' intimate relationships and supporting their rehabilitation. This study supports the mission of the 2018-2024 Strategic Plan of the Department of Veterans Affairs by improving Veterans' relationship functioning to enhance their overall quality of life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants will be couples consisting of a Veteran referred from a mental health care clinic at VA San Diego Healthcare System and their spouse or romantic partner who is willing to participate
* Couples must:
* both speak, read, and write English
* be married, living together, or in a relationship for at least 12 months
* endorse clinically significant relationship distress by one or both partner's reports (i.e., \< 104.5 on the Couples Satisfaction Index-32)
* have internet access sufficient to complete the online program and attend telehealth visits
* be willing to have telehealth coach sessions audio-recorded
Exclusion Criteria:
* Couples will be excluded if either partner reports
* an active substance use disorder within the past three months (i.e., 2+ on the TAPS screening tool for a single substance followed by positive diagnosis in clinical interview)
* a diagnosis of a psychotic or bipolar disorder with current uncontrolled symptoms (by self-report)
* a diagnosis of severe cognitive impairment or intellectual disability (by self-report)
* severe physical or sexual relationship aggression during the past 12 months (i.e., 10+ on the Hurt-Insult-Threaten-Scream \[HITS\] screening tool followed by clinical interview)
* current suicidal ideation or behavior determined to be high-risk according to current VA clinical assessment protocols (i.e., "yes" on any high-risk items on the Columbia Suicide Severity Rating Scale)
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.