Relationship DistressVA-ORNCT05136651
Clinical Trial of the Online OurRelationship Program for Veteran Couples
A study testing OurRelationship in people with Relationship Distress, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relationship Distress
- What is being tested?
- OurRelationship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: 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.
Read the 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.
- Conditions
- Relationship Distress
- Being tested
- OurRelationship
- Keywords
- couples, OurRelationship, relationship, couples therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OurRelationshipBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Couples assigned to the Immediate Treatment condition will begin the OurRelationship program immediately following random assignment. Receives: 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. Receives: Behavioral: OurRelationship |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Secondary outcomes (28)
Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Communication Skills Test (CST-10)
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.
Measured: Baseline
Communication Skills Test (CST-10)
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.
Measured: Mid-treatment (approx. 1 month post-randomization)
Communication Skills Test (CST-10)
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.
Measured: Post-treatment (approx. 2 months post-randomization)
Communication Skills Test (CST-10)
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.
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Communication Danger Signs Scale (CDS)
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.
Measured: Baseline
Communication Danger Signs Scale (CDS)
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.
Measured: Mid-treatment (approx. 1 month post-randomization)
Communication Danger Signs Scale (CDS)
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.
Measured: Post-treatment (approx. 2 months post-randomization)
Communication Danger Signs Scale (CDS)
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.
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
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.
Measured: Baseline
Revised Conflict Tactics Scale, Short Form (CTS-2S)
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.
Measured: Mid-treatment (approx. 1 month post-randomization)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
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.
Measured: Post-treatment (approx. 2 months post-randomization)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
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.
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Brief Inventory of Psychosocial Functioning (B-IPF)
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).
Measured: Baseline
Brief Inventory of Psychosocial Functioning (B-IPF)
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).
Measured: Mid-treatment (approx. 1 month post-randomization)
Brief Inventory of Psychosocial Functioning (B-IPF)
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).
Measured: Post-treatment (approx. 2 months post-randomization)
Brief Inventory of Psychosocial Functioning (B-IPF)
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).
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Brunnsviken Brief Quality of life scale (BBQ)
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.
Measured: Baseline
Brunnsviken Brief Quality of life scale (BBQ)
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.
Measured: Mid-treatment (approx. 1 month post-randomization)
Brunnsviken Brief Quality of life scale (BBQ)
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.
Measured: Post-treatment (approx. 2 months post-randomization)
Brunnsviken Brief Quality of life scale (BBQ)
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.
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Family Role Performance Scale (FRPS)
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.
Measured: Baseline
Family Role Performance Scale (FRPS)
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.
Measured: Mid-treatment (approx. 1 month post-randomization)
Family Role Performance Scale (FRPS)
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.
Measured: Post-treatment (approx. 2 months post-randomization)
Family Role Performance Scale (FRPS)
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.
Measured: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: Baseline
Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: Mid-treatment (approx. 1 month post-randomization)
Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: Post-treatment (approx. 2 months post-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start6 Feb 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relationship DistressStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kayla C. Knopp, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136651
- Sponsor's protocol ID
- D3777-W
- Acronym
- VA-OR
- Status last verified
- Jul 2026
- First submitted
- 15 Nov 2021
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33048570Doss 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.
PubMed 32134290Doss 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.
PubMed 26999504
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of OurRelationship, a Scalable Digital Intervention for Veteran Couples
- ClinicalTrials.gov ID
- NCT05136651
- Acronym / sponsor ID
- VA-OR / D3777-W
- Conditions
- Relationship Distress
- Keywords
- couples, OurRelationship, relationship, couples therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 29 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: OurRelationshipCouples assigned to the Immediate Treatment condition will begin the OurRelationship program immediately following random assignment. |
| Waitlist Control | Other | Behavioral: OurRelationshipCouples assigned to the Waitlist Control condition will begin the OurRelationship program following a 2-month delay after random assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (7 listed)
- Couples will be excluded if either partner reports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OurRelationshipThe 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. | Behavioural | Immediate Treatment, Waitlist Control |
Primary outcome
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.
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.
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.
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.
28 secondary outcomes
Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: 6-month follow-up (approx. 6 months following completion of post-treatment assessment)
Communication Skills Test (CST-10)
Time frame: Baseline
Communication Skills Test (CST-10)
Time frame: Mid-treatment (approx. 1 month post-randomization)
Communication Skills Test (CST-10)
Time frame: 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)
Communication Danger Signs Scale (CDS)
Time frame: Baseline
Communication Danger Signs Scale (CDS)
Time frame: Mid-treatment (approx. 1 month post-randomization)
Communication Danger Signs Scale (CDS)
Time frame: 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)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
Time frame: Baseline
Revised Conflict Tactics Scale, Short Form (CTS-2S)
Time frame: Mid-treatment (approx. 1 month post-randomization)
Revised Conflict Tactics Scale, Short Form (CTS-2S)
Time frame: 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)
Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: Baseline
Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: Mid-treatment (approx. 1 month post-randomization)
Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: 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)
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: Baseline
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: Mid-treatment (approx. 1 month post-randomization)
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: 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)
Family Role Performance Scale (FRPS)
Time frame: Baseline
Family Role Performance Scale (FRPS)
Time frame: Mid-treatment (approx. 1 month post-randomization)
Family Role Performance Scale (FRPS)
Time frame: 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)
Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Baseline
Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Mid-treatment (approx. 1 month post-randomization)
Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Post-treatment (approx. 2 months post-randomization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 33048570Georgia 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.
- Background: PubMed 32134290Doss 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.
- Background: PubMed 26999504Doss 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.
- OurRelationship ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Relationship Distress
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Enrolling by invitationPhase 1/2
Gene Therapy for IGHMBP2-Related Diseases
SMARD1, CMT2S
RecruitingPhase 2
Duloxetine in Inflammatory Bowel Diseases
Inflammatory Bowel Diseases
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kayla C. Knopp, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OurRelationship in people with Relationship Distress, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Couples Satisfaction Index (CSI-32) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136651, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.