NCT05136651

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Feb 2023Apr 2027

First Submitted

Initial submission to the registry

November 15, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3.7 years

First QC Date

November 15, 2021

Last Update Submit

December 10, 2025

Conditions

Relationship Distress

Keywords

couplesOurRelationshiprelationshipcouples therapy

Outcome Measures

Primary Outcomes (4)

  • Couples Satisfaction Index (CSI-32)

    The Couples Satisfaction Index (CSI-32) is a 32-item measure designed to assess relationship satisfaction of intact (married, cohabiting or dating) couples. The measure includes items aimed at assessing the presence of problems between individuals and the intensity of such problems. Total scores can range from 0 to 161. Higher scores indicate higher levels of relationship satisfaction. CSI-32 scores falling below 104.5 suggest clinical relationship distress.

    Baseline

  • Couples Satisfaction Index (CSI-32)

    The Couples Satisfaction Index (CSI-32) is a 32-item measure designed to assess relationship satisfaction of intact (married, cohabiting or dating) couples. The measure includes items aimed at assessing the presence of problems between individuals and the intensity of such problems. Total scores can range from 0 to 161. Higher scores indicate higher levels of relationship satisfaction. CSI-32 scores falling below 104.5 suggest clinical relationship distress.

    Mid-treatment (approx. 1 month post-randomization)

  • Couples Satisfaction Index (CSI-32)

    The Couples Satisfaction Index (CSI-32) is a 32-item measure designed to assess relationship satisfaction of intact (married, cohabiting or dating) couples. The measure includes items aimed at assessing the presence of problems between individuals and the intensity of such problems. Total scores can range from 0 to 161. Higher scores indicate higher levels of relationship satisfaction. CSI-32 scores falling below 104.5 suggest clinical relationship distress.

    Post-treatment (approx. 2 months post-randomization)

  • Couples Satisfaction Index (CSI-32)

    The Couples Satisfaction Index (CSI-32) is a 32-item measure designed to assess relationship satisfaction of intact (married, cohabiting or dating) couples. The measure includes items aimed at assessing the presence of problems between individuals and the intensity of such problems. Total scores can range from 0 to 161. Higher scores indicate higher levels of relationship satisfaction. CSI-32 scores falling below 104.5 suggest clinical relationship distress.

    6-month follow-up (approx. 6 months following completion of post-treatment assessment)

Secondary Outcomes (28)

  • Depression, Anxiety, and Stress Scale (DASS-21)

    6-month follow-up (approx. 6 months following completion of post-treatment assessment)

  • Communication Skills Test (CST-10)

    Baseline

  • Communication Skills Test (CST-10)

    Mid-treatment (approx. 1 month post-randomization)

  • Communication Skills Test (CST-10)

    Post-treatment (approx. 2 months post-randomization)

  • Communication Skills Test (CST-10)

    6-month follow-up (approx. 6 months following completion of post-treatment assessment)

  • +23 more secondary outcomes

Other Outcomes (2)

  • Client Satisfaction Questionnaire (CSQ-8)

    Post-treatment (approx. 2 months post-randomization)

  • Working Alliance Inventory - Short Revised (WAI-SR)

    Post-treatment (approx. 2 months post-randomization)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Couples assigned to the Immediate Treatment condition will begin the OurRelationship program immediately following random assignment.

Behavioral: OurRelationship

Waitlist Control

OTHER

Couples assigned to the Waitlist Control condition will begin the OurRelationship program following a 2-month delay after random assignment.

Behavioral: OurRelationship

Interventions

OurRelationshipBEHAVIORAL

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 TreatmentWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 33048570BACKGROUND

  • 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.

    PMID: 32134290BACKGROUND

  • 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.

    PMID: 26999504BACKGROUND

Related Links

Study Officials

  • Kayla C. Knopp, PhD

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla C Knopp, PhD

CONTACT

(858) 642-1094Kayla.Knopp@va.gov

Leslie A Morland, PsyD

CONTACT

(619) 497-8406Leslie.Morland@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 29, 2021

Study Start

February 6, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)