Clinical trial NCT05136651: OurRelationship for Veteran Couples
Official title: Clinical Trial of OurRelationship, a Scalable Digital Intervention for Veteran Couples
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Relationship Distress
Keywords: couples
OurRelationship
relationship
couples therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-11-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist-control design. Participants will be randomly assigned to receive either immediate treatment or treatment after a 2-month waiting period. The intervention received is the same in both conditions; only the timing differs.
Primary purpose: TREATMENT

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 1163.04 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 (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.

Eligibility criteria: 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)
  * suicide-related hospitalizations within the past 12 months (by self-report)

Primary outcomes:
measure: Couples Satisfaction Index (CSI-32)
timeFrame: Baseline
measure: Couples Satisfaction Index (CSI-32)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Couples Satisfaction Index (CSI-32)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Couples Satisfaction Index (CSI-32)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Secondary outcomes:
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
measure: Communication Skills Test (CST-10)
timeFrame: Baseline
measure: Communication Skills Test (CST-10)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Communication Skills Test (CST-10)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Communication Skills Test (CST-10)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
measure: Communication Danger Signs Scale (CDS)
timeFrame: Baseline
measure: Communication Danger Signs Scale (CDS)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Communication Danger Signs Scale (CDS)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Communication Danger Signs Scale (CDS)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
measure: Revised Conflict Tactics Scale, Short Form (CTS-2S)
timeFrame: Baseline
measure: Revised Conflict Tactics Scale, Short Form (CTS-2S)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Revised Conflict Tactics Scale, Short Form (CTS-2S)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Revised Conflict Tactics Scale, Short Form (CTS-2S)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
measure: Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: Baseline
measure: Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: Baseline
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
measure: Family Role Performance Scale (FRPS)
timeFrame: Baseline
measure: Family Role Performance Scale (FRPS)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Family Role Performance Scale (FRPS)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Family Role Performance Scale (FRPS)
timeFrame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Baseline
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Mid-treatment (approx. 1 month post-randomization)
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Post-treatment (approx. 2 months post-randomization)
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment (approx. 2 months post-randomization)
measure: Working Alliance Inventory - Short Revised (WAI-SR)
timeFrame: Post-treatment (approx. 2 months post-randomization)
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Kayla C. Knopp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.