Clinical Trial of the Online OurRelationship Program for Veteran Couples (VA-OR)

July 30, 2026 updated by: VA Office of Research and Development

Clinical Trial of OurRelationship, a Scalable Digital Intervention for Veteran Couples

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Treatment
Couples assigned to the Immediate Treatment condition will begin the OurRelationship program immediately following random assignment.
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.
Other: Waitlist Control
Couples assigned to the Waitlist Control condition will begin the OurRelationship program following a 2-month delay after random assignment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Couples Satisfaction Index (CSI-32)
Time Frame: Baseline
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)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
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)
Time Frame: Post-treatment (approx. 2 months post-randomization)
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)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Psychological distress will be measured with the Depression, Anxiety, and Stress Scale (DASS-21), a 21-item self-report questionnaire measuring three dimensions of negative emotional states. Each of the three dimensions is measured with 7 items on a 0 to 3 point scale, and total scores are calculated by summing the items and then doubling the sum score for equivalence to the longer DASS-42. Total scores for the three dimensions range from 0 to 42.
6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Communication Skills Test (CST-10)
Time Frame: Baseline
Positive communication will be measured using the Communication Skills Test (CST), a 10-item assessment of self-reported use of adaptive communication skills (e.g., paraphrasing, time-out). Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing better communication skills.
Baseline
Communication Skills Test (CST-10)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
Positive communication will be measured using the Communication Skills Test (CST), a 10-item assessment of self-reported use of adaptive communication skills (e.g., paraphrasing, time-out). Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing better communication skills.
Mid-treatment (approx. 1 month post-randomization)
Communication Skills Test (CST-10)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Positive communication will be measured using the Communication Skills Test (CST), a 10-item assessment of self-reported use of adaptive communication skills (e.g., paraphrasing, time-out). Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing better communication skills.
Post-treatment (approx. 2 months post-randomization)
Communication Skills Test (CST-10)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Positive communication will be measured using the Communication Skills Test (CST), a 10-item assessment of self-reported use of adaptive communication skills (e.g., paraphrasing, time-out). Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing better communication skills.
6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Communication Danger Signs Scale (CDS)
Time Frame: Baseline
Negative communication will be measured using the Communication Danger Signs scale (CDS), an 8-item scale assessing specific negative communication behaviors that are associated with relationship dissolution. Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing more negative communication.
Baseline
Communication Danger Signs Scale (CDS)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
Negative communication will be measured using the Communication Danger Signs scale (CDS), an 8-item scale assessing specific negative communication behaviors that are associated with relationship dissolution. Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing more negative communication.
Mid-treatment (approx. 1 month post-randomization)
Communication Danger Signs Scale (CDS)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Negative communication will be measured using the Communication Danger Signs scale (CDS), an 8-item scale assessing specific negative communication behaviors that are associated with relationship dissolution. Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing more negative communication.
Post-treatment (approx. 2 months post-randomization)
Communication Danger Signs Scale (CDS)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Negative communication will be measured using the Communication Danger Signs scale (CDS), an 8-item scale assessing specific negative communication behaviors that are associated with relationship dissolution. Responses use a 7-point Likert-type scale and are averaged to range from 0 to 7, with higher scores representing more negative communication.
6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
Time Frame: Baseline
Conflict/aggression will be measured using the Revised Conflict Tactics Scale (CTS-2), a 20-item measure of 5 domains of relationship conflict and aggression perpetrated by the respondent and their partner. Respondents report how often each event occurred during the past month on a scale from 0 (never) to 6 (more than 20 times) Each domain is scored separately using either sum scores ranging from 0 to 24, chronicity scores ranging from 1 to 80, or prevalence scores ranging from 0 to 1.
Baseline
Revised Conflict Tactics Scale, Short Form (CTS-2S)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
Conflict/aggression will be measured using the Revised Conflict Tactics Scale (CTS-2), a 20-item measure of 5 domains of relationship conflict and aggression perpetrated by the respondent and their partner. Respondents report how often each event occurred during the past month on a scale from 0 (never) to 6 (more than 20 times) Each domain is scored separately using either sum scores ranging from 0 to 24, chronicity scores ranging from 1 to 80, or prevalence scores ranging from 0 to 1.
Mid-treatment (approx. 1 month post-randomization)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Conflict/aggression will be measured using the Revised Conflict Tactics Scale (CTS-2), a 20-item measure of 5 domains of relationship conflict and aggression perpetrated by the respondent and their partner. Respondents report how often each event occurred during the past month on a scale from 0 (never) to 6 (more than 20 times) Each domain is scored separately using either sum scores ranging from 0 to 24, chronicity scores ranging from 1 to 80, or prevalence scores ranging from 0 to 1.
Post-treatment (approx. 2 months post-randomization)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Conflict/aggression will be measured using the Revised Conflict Tactics Scale (CTS-2), a 20-item measure of 5 domains of relationship conflict and aggression perpetrated by the respondent and their partner. Respondents report how often each event occurred during the past month on a scale from 0 (never) to 6 (more than 20 times) Each domain is scored separately using either sum scores ranging from 0 to 24, chronicity scores ranging from 1 to 80, or prevalence scores ranging from 0 to 1.
6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Brief Inventory of Psychosocial Functioning (B-IPF)
Time Frame: Baseline
Psychosocial functioning will be measured using the Brief Inventory of Psychosocial Functioning (B-IPF), a 7-item measure assessing seven domains of overall functioning. Scores are calculated as percentages and range from 0 to 100, with higher scores indicating more psychosocial dysfunction (i.e., worse psychosocial functioning).
Baseline
Brief Inventory of Psychosocial Functioning (B-IPF)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
Psychosocial functioning will be measured using the Brief Inventory of Psychosocial Functioning (B-IPF), a 7-item measure assessing seven domains of overall functioning. Scores are calculated as percentages and range from 0 to 100, with higher scores indicating more psychosocial dysfunction (i.e., worse psychosocial functioning).
Mid-treatment (approx. 1 month post-randomization)
Brief Inventory of Psychosocial Functioning (B-IPF)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Psychosocial functioning will be measured using the Brief Inventory of Psychosocial Functioning (B-IPF), a 7-item measure assessing seven domains of overall functioning. Scores are calculated as percentages and range from 0 to 100, with higher scores indicating more psychosocial dysfunction (i.e., worse psychosocial functioning).
Post-treatment (approx. 2 months post-randomization)
Brief Inventory of Psychosocial Functioning (B-IPF)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Psychosocial functioning will be measured using the Brief Inventory of Psychosocial Functioning (B-IPF), a 7-item measure assessing seven domains of overall functioning. Scores are calculated as percentages and range from 0 to 100, with higher scores indicating more psychosocial dysfunction (i.e., worse psychosocial functioning).
6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Brunnsviken Brief Quality of life scale (BBQ)
Time Frame: Baseline
The Brunnsviken Brief Quality of life scale (BBQ) measures subjective quality of life validated for use with both clinical and non-clinical samples, forming an overall life satisfaction score comprised of six life domains (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) assessed with two items each (importance and satisfaction). Scores are calculated by summing the products of the satisfaction and importance scores for each domain. Sum scores can range from 0 to 96, with higher scores indicating better quality of life.
Baseline
Brunnsviken Brief Quality of life scale (BBQ)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
The Brunnsviken Brief Quality of life scale (BBQ) measures subjective quality of life validated for use with both clinical and non-clinical samples, forming an overall life satisfaction score comprised of six life domains (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) assessed with two items each (importance and satisfaction). Scores are calculated by summing the products of the satisfaction and importance scores for each domain. Sum scores can range from 0 to 96, with higher scores indicating better quality of life.
Mid-treatment (approx. 1 month post-randomization)
Brunnsviken Brief Quality of life scale (BBQ)
Time Frame: Post-treatment (approx. 2 months post-randomization)
The Brunnsviken Brief Quality of life scale (BBQ) measures subjective quality of life validated for use with both clinical and non-clinical samples, forming an overall life satisfaction score comprised of six life domains (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) assessed with two items each (importance and satisfaction). Scores are calculated by summing the products of the satisfaction and importance scores for each domain. Sum scores can range from 0 to 96, with higher scores indicating better quality of life.
Post-treatment (approx. 2 months post-randomization)
Brunnsviken Brief Quality of life scale (BBQ)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
The Brunnsviken Brief Quality of life scale (BBQ) measures subjective quality of life validated for use with both clinical and non-clinical samples, forming an overall life satisfaction score comprised of six life domains (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) assessed with two items each (importance and satisfaction). Scores are calculated by summing the products of the satisfaction and importance scores for each domain. Sum scores can range from 0 to 96, with higher scores indicating better quality of life.
6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Family Role Performance Scale (FRPS)
Time Frame: Baseline
Family role participation will be measured with the Family Role Performance Scale (FRPS), an 8-item self-report measure of the degree to which respondents fulfill expectations in two domains of family functioning (task- or relationship-oriented). The items are rated from 1 to 5, with higher sum scores (total range 8 to 40) indicating better fulfillment of family role expectations.
Baseline
Family Role Performance Scale (FRPS)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
Family role participation will be measured with the Family Role Performance Scale (FRPS), an 8-item self-report measure of the degree to which respondents fulfill expectations in two domains of family functioning (task- or relationship-oriented). The items are rated from 1 to 5, with higher sum scores (total range 8 to 40) indicating better fulfillment of family role expectations.
Mid-treatment (approx. 1 month post-randomization)
Family Role Performance Scale (FRPS)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Family role participation will be measured with the Family Role Performance Scale (FRPS), an 8-item self-report measure of the degree to which respondents fulfill expectations in two domains of family functioning (task- or relationship-oriented). The items are rated from 1 to 5, with higher sum scores (total range 8 to 40) indicating better fulfillment of family role expectations.
Post-treatment (approx. 2 months post-randomization)
Family Role Performance Scale (FRPS)
Time Frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Family role participation will be measured with the Family Role Performance Scale (FRPS), an 8-item self-report measure of the degree to which respondents fulfill expectations in two domains of family functioning (task- or relationship-oriented). The items are rated from 1 to 5, with higher sum scores (total range 8 to 40) indicating better fulfillment of family role expectations.
6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: Baseline
Psychological distress will be measured with the Depression, Anxiety, and Stress Scale (DASS-21), a 21-item self-report questionnaire measuring three dimensions of negative emotional states. Each of the three dimensions is measured with 7 items on a 0 to 3 point scale, and total scores are calculated by summing the items and then doubling the sum score for equivalence to the longer DASS-42. Total scores for the three dimensions range from 0 to 42.
Baseline
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: Mid-treatment (approx. 1 month post-randomization)
Psychological distress will be measured with the Depression, Anxiety, and Stress Scale (DASS-21), a 21-item self-report questionnaire measuring three dimensions of negative emotional states. Each of the three dimensions is measured with 7 items on a 0 to 3 point scale, and total scores are calculated by summing the items and then doubling the sum score for equivalence to the longer DASS-42. Total scores for the three dimensions range from 0 to 42.
Mid-treatment (approx. 1 month post-randomization)
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Psychological distress will be measured with the Depression, Anxiety, and Stress Scale (DASS-21), a 21-item self-report questionnaire measuring three dimensions of negative emotional states. Each of the three dimensions is measured with 7 items on a 0 to 3 point scale, and total scores are calculated by summing the items and then doubling the sum score for equivalence to the longer DASS-42. Total scores for the three dimensions range from 0 to 42.
Post-treatment (approx. 2 months post-randomization)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Program satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measure of client satisfaction with treatment designed for healthcare settings. Sum scores range from 8 to 32, with higher scores indicating better satisfaction with treatment services.
Post-treatment (approx. 2 months post-randomization)
Working Alliance Inventory - Short Revised (WAI-SR)
Time Frame: Post-treatment (approx. 2 months post-randomization)
Working alliance will be measured using the Working Alliance Inventory - Short Revised (WAI-SR), a 12-item measure of therapeutic working alliance. Sum scores range from 12 to 84, with higher scores indicating better therapeutic alliance.
Post-treatment (approx. 2 months post-randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kayla C. Knopp, PhD, VA San Diego Healthcare System, San Diego, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • D3777-W

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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