Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-02-06
2027-04-30
Brief Summary
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Detailed Description
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However, access to couples' interventions is limited, and traditional couple psychotherapy is not sufficiently scalable. Although most VA medical centers have trained couple therapists, they are limited in number and location, and they are underutilized due to numerous logistical barriers couples face including coordinating schedules, dual time off work, childcare, and stigma. Unsurprisingly, over 60% of divorced couples never accessed couples' treatment, and Veterans spend four to seven years in relationship distress before getting help. Digital health is a critical part of solving problems of access to care. Because digital health interventions for couples can provide flexible access to evidence-based relationship interventions, they are an essential part of providing the continuum of family mental health care mandated by VHA.
OurRelationship is an online adaptation of Integrative Behavioral Couple Therapy (IBCT), the evidence-based protocol for couple therapy currently in use in the VA healthcare system. It combines eight hours of a self-paced online couples' program with three 20-minute telehealth coaching sessions. OurRelationship is a scalable, transdiagnostic, evidence-based couples' intervention that can help provide access to flexible family mental health services. Several RCTs demonstrate OurRelationship improves both relationship functioning and individual mental health. A small secondary analysis from an RCT supports the use of OurRelationship with Veterans in the community, and the pilot data from 13 couples recruited over two months in the VA San Diego Healthcare System (VASDHS) indicate that Veterans find OurRelationship appealing and helpful. However, OurRelationship has not yet been empirically evaluated with a Veteran population in a VA care setting.
The scientific goals of this CDA-2 project are to evaluate the feasibility, acceptability, and efficacy of OurRelationship for improving relationship and individual functioning among Veteran couples. The proposed 5-year study is a 2-month waitlist-controlled randomized clinical trial. The investigators aim to serve 90 couples (Veterans and their partners, N = 180) who report relationship distress, recruited from mental health clinics within VASDHS. The sample and recruitment plan is feasible based on the investigators' pilot testing and on prior RCTs. Data on outcomes including relationship functioning and behavior (e.g., communication, conflict), individual functioning (e.g., quality of life, family role), and psychiatric symptoms (depression, anxiety) will be collected at baseline, mid-program, post-program, and a 6-month follow-up. The investigators will collect participant feedback via semi-structured interviews and ratings of program satisfaction and therapeutic alliance.
The Specific Aims are:
Aim 1: To examine feasibility and acceptability of implementing OurRelationship in a VA setting with Veterans and their partners, evidenced by quantitative (recruitment, retention, and satisfaction ratings) and qualitative data (semi-structured interviews soliciting participant feedback).
Aim 2: To evaluate efficacy of the OurRelationship program for Veterans and their partners, as evidenced by statistically and clinically significant improvements in relationship and individual functioning that are maintained for 6 months post-intervention.
Aim 3: To explore mediation of improvements in individual functional outcomes by improvements in relationship functioning.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Waitlist Control
Couples assigned to the Waitlist Control condition will begin the OurRelationship program following a 2-month delay after random assignment.
OurRelationship
The OurRelationship Program is an online adaptation of Integrative Behavioral Couple Therapy (IBCT). It consists of 3 modules that couples complete over the course of 6-8 weeks. Couples also receive a 30-minute coaching appointment following completion of each module.
Immediate Treatment
Couples assigned to the Immediate Treatment condition will begin the OurRelationship program immediately following random assignment.
OurRelationship
The OurRelationship Program is an online adaptation of Integrative Behavioral Couple Therapy (IBCT). It consists of 3 modules that couples complete over the course of 6-8 weeks. Couples also receive a 30-minute coaching appointment following completion of each module.
Interventions
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OurRelationship
The OurRelationship Program is an online adaptation of Integrative Behavioral Couple Therapy (IBCT). It consists of 3 modules that couples complete over the course of 6-8 weeks. Couples also receive a 30-minute coaching appointment following completion of each module.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
* suicide-related hospitalizations within the past 12 months (by self-report)
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Kayla C. Knopp, PhD
Role: PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA
Locations
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VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Kayla C Knopp, PhD
Role: primary
References
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Georgia Salivar E, Knopp K, Roddy MK, Morland LA, Doss BD. Effectiveness of online OurRelationship and ePREP programs for low-income military couples. J Consult Clin Psychol. 2020 Oct;88(10):899-906. doi: 10.1037/ccp0000606.
Doss BD, Knopp K, Roddy MK, Rothman K, Hatch SG, Rhoades GK. Online programs improve relationship functioning for distressed low-income couples: Results from a nationwide randomized controlled trial. J Consult Clin Psychol. 2020 Apr;88(4):283-294. doi: 10.1037/ccp0000479.
Doss BD, Cicila LN, Georgia EJ, Roddy MK, Nowlan KM, Benson LA, Christensen A. A randomized controlled trial of the web-based OurRelationship program: Effects on relationship and individual functioning. J Consult Clin Psychol. 2016 Apr;84(4):285-96. doi: 10.1037/ccp0000063. Epub 2016 Jan 25.
Related Links
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OurRelationship Program
Other Identifiers
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D3777-W
Identifier Type: -
Identifier Source: org_study_id