Relationship Distress Clinical Trial
— VA-OROfficial 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.
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | April 30, 2027 |
| Est. primary completion date | October 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| VA Office of Research and Development |
United States,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Client Satisfaction Questionnaire (CSQ-8) | 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) | |
| Other | Working Alliance Inventory - Short Revised (WAI-SR) | 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) | |
| Primary | 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 | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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 | 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. | 6-month follow-up (approx. 6 months following completion of post-treatment assessment) | |
| Secondary | 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. | Baseline | |
| Secondary | 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. | Mid-treatment (approx. 1 month post-randomization) | |
| Secondary | 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. | Post-treatment (approx. 2 months post-randomization) | |
| Secondary | 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. | 6-month follow-up (approx. 6 months following completion of post-treatment assessment) | |
| Secondary | 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. | Baseline | |
| Secondary | 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. | Mid-treatment (approx. 1 month post-randomization) | |
| Secondary | 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. | Post-treatment (approx. 2 months post-randomization) | |
| Secondary | 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. | 6-month follow-up (approx. 6 months following completion of post-treatment assessment) | |
| Secondary | 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. | Baseline | |
| Secondary | 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. | Mid-treatment (approx. 1 month post-randomization) | |
| Secondary | 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. | Post-treatment (approx. 2 months post-randomization) | |
| Secondary | 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. | 6-month follow-up (approx. 6 months following completion of post-treatment assessment) | |
| Secondary | 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). | Baseline | |
| Secondary | 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). | Mid-treatment (approx. 1 month post-randomization) | |
| Secondary | 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). | Post-treatment (approx. 2 months post-randomization) | |
| Secondary | 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). | 6-month follow-up (approx. 6 months following completion of post-treatment assessment) | |
| Secondary | 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. | Baseline | |
| Secondary | 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. | Mid-treatment (approx. 1 month post-randomization) | |
| Secondary | 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. | Post-treatment (approx. 2 months post-randomization) | |
| Secondary | 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. | 6-month follow-up (approx. 6 months following completion of post-treatment assessment) | |
| Secondary | 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. | Baseline | |
| Secondary | 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. | Mid-treatment (approx. 1 month post-randomization) | |
| Secondary | 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. | Post-treatment (approx. 2 months post-randomization) | |
| Secondary | 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. | 6-month follow-up (approx. 6 months following completion of post-treatment assessment) | |
| Secondary | 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. | Baseline | |
| Secondary | 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. | Mid-treatment (approx. 1 month post-randomization) | |
| Secondary | 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. | Post-treatment (approx. 2 months post-randomization) |
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