Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05136651
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2021-11-15
Brief Title:
OurRelationship for Veteran Couples
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Clinical Trial of OurRelationship a Scalable Digital Intervention for Veteran Couples
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VA-OR
Brief 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
Detailed Description:
Over 75 of Veterans referred for behavioral health assessments endorse significant relationship concerns including 60 reporting mild to severe intimate partner violence Relationship problems increase risk of cardiovascular illness exacerbate psychiatric symptoms impair social and work functioning and are the most common precipitants of suicidal ideation and attempts for Veterans Healthy intimate relationships are a crucial part of wellness resilience and recovery and biopsychosocial theories of rehabilitation psychology stress the importance of relationships Military Veterans have experienced numerous stressors that increase risk of relationship distress including deployment and reintegration cycles frequent relocation and physical and mental health sequelae of trauma Accordingly VHA directive 116304 in 2019 mandated that all Veterans have access to a flexible continuum of family mental health services as part of rehabilitation efforts
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 eg communication conflict individual functioning eg 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
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 eg communication conflict individual functioning eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None