An interventional study of Brief Relationship Checkup (BRC) in Relationship Distress, sponsored by Canandaigua VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Canandaigua VA Medical Center · Not applicable, Interventional, and Treatment
The goal of this pilot trial is to study the Brief Relationship Checkup (BRC) program for Veterans with a combination of mental health and relationship concerns.
BRC has been studied in Air Force primary care, but has never been tested in the Department of Veterans Affairs. To prepare for a larger study of BRC, the investigators asked the following questions:
Participants completed an initial interview, attended the BRC program, and completed a follow-up interview.
PURPOSE: Relationship distress is a common problem for Veterans with mental health concerns. Relationship treatments like couple therapy are effective, but studies in the Department of Veterans Affairs (VA) find that they are infrequently used and have high dropout rates. One possible solution is for VA to offer Relationship Checkups, a short program that helps couples commit to concrete steps to improve their relationship. A brief version of the program designed for Air Force primary care -- called the Brief Relationship Checkup (BRC) for the purpose of the study -- may be an especially good fit for VA primary care or outpatient mental health teams.
RESEARCH PLAN: This study is a single-arm pilot trial of BRC in 20 couples. that are in distressed committed relationship where at least one partner is a Veteran who screens positive on a primary care mental health screen for common suicide risk factors including suicide ideation, depression, PTSD, or alcohol misuse (the "Identified Patient"). Participants provided initial ratings of outcomes in separate baseline sessions, completed BRC, and then completed separate post-treatment interviews and questionnaires.
SPECIFIC AIMS:
AIM 1: Evaluate feasibility of conducting a BRC trial in Veterans with mental health concerns. This includes recruitment rate, completion rate, and provider adherence to protocol.
AIM 2: Pilot outcomes that can be used to evaluate pre-post change in future studies of BRC. This includes relationship functioning, suicide risk factors, and treatment utilization.
AIM 3: Inform continued refinement of BRC to be suitable to the needs of Veterans and their partners. This includes examining current acceptability and using open-ended interviews.
Exclusion Criteria:
Couples in the experimental condition will participate in three joint sessions of the Brief Relationship Checkup (BRC; Cordova 2014; Cigrang et al., 2016). This program has been tested in Air Force Primary Care but we do not know if veterans with mental health concerns will be able to attend it (feasibility), complete it safely (tolerability), and enjoy it (acceptability).
Behavioral: Brief Relationship Checkup (BRC)
The investigators are using the three 30-minute session protocol developed for Air Force Primary Care (Cigrang et al., 2016). Although it is simply referred to as the "Marriage Checkup" in that manuscript, the investigators use the name BRC to distinguish it from many other versions of Dr. James Cordova's Marriage Checkup (Cordova, 2014) adapted for different settings. Sessions in this version are briefer than other versions (30 mins vs. 60-90 mins) and this trial does not have any eligibility restrictions based on marital status.
Also known as: Marriage Checkup, Relationship Checkup
Relationship Functioning
Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores \< 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.
Time frame: Pre-treatment
Relationship Functioning
Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores \< 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Emotional Intimacy/Mutual Responsiveness
Emotional Intimacy will be measured using the Perceived Responsiveness \& Insensitivity Scale (PRI). The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/validating. The PRI has a minimum of 0 and a maximum of 80, with higher scores indicating greater sense of validation/understanding from one's partner.
Time frame: Pre-treatment
Emotional Intimacy/Mutual Responsiveness
Emotional Intimacy will be measured using the Perceived Responsiveness \& Insensitivity Scale (PRI). The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/validating. The PRI has a minimum of 0 and a maximum of 80, with higher scores indicating greater sense of validation/understanding (i.e., greater emotional intimacy).
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Depressive Symptoms
Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.
Time frame: Pre-treatment
Depressive Symptoms
Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Perceived Burdensomeness
Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.
Time frame: Pre-treatment
Perceived Burdensomeness
Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Thwarted Belongingness
Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.
Time frame: Pre-treatment
Thwarted Belongingness
Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Suicide Ideation Severity
Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.
Time frame: Pre-treatment
Suicide Ideation Severity
Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Treatment Acceptability
Treatment acceptability was assessed using the Client Satisfaction Questionnaire (CSQ, Larsen et al., 1979). Scores range from 1-4 with scores greater than 3 representing satisfaction with the treatment.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Number of Mental Health and Family Contacts
Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).
Time frame: 90 day period before pre-treatment session
Number of Mental Health and Family Contacts
Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).
Time frame: 90 day period after final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo)
| Milestone | Brief Relationship Checkup |
|---|---|
| Started | 40 |
| Completed | 33 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 5 |
Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores \< 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Relationship Functioning | 84.99 ± 6.60 | 90.90 ± 6.60 |
Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores \< 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Relationship Functioning | 117.66 ± 6.97 | 106.81 ± 6.88 |
Emotional Intimacy will be measured using the Perceived Responsiveness \& Insensitivity Scale (PRI). The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/validating. The PRI has a minimum of 0 and a maximum of 80, with higher scores indicating greater sense of validation/understanding from one's partner.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Emotional Intimacy/Mutual Responsiveness | 41.64 ± 4.49 | 44.80 ± 4.49 |
Emotional Intimacy will be measured using the Perceived Responsiveness \& Insensitivity Scale (PRI). The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/validating. The PRI has a minimum of 0 and a maximum of 80, with higher scores indicating greater sense of validation/understanding (i.e., greater emotional intimacy).
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Emotional Intimacy/Mutual Responsiveness | 58.87 ± 4.65 | 50.67 ± 4.61 |
Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Depressive Symptoms | 11.00 ± 0.98 | 7.50 ± 0.98 |
Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Depressive Symptoms | 8.17 ± 1.08 | 4.24 ± 1.06 |
Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Perceived Burdensomeness | 11.14 ± 1.05 | 7.84 ± 1.07 |
Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Perceived Burdensomeness | 9.76 ± 1.09 | 7.06 ± 1.09 |
Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Thwarted Belongingness | 31.26 ± 2.43 | 28.32 ± 2.47 |
Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Thwarted Belongingness | 23.75 ± 2.55 | 23.50 ± 2.55 |
Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.
| Participants | Screened Veteran | Second Partner |
|---|---|---|
| No ideation (Score=0) | 18 | 20 |
| Passive Death Ideation (Score=1) | 1 | 0 |
| Ideation with Plan (Score=3) | 1 | 0 |
Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.
| Participants | Screened Veteran | Second Partner |
|---|---|---|
| No Ideation (Score=0) | 14 | 17 |
| Passive Death Ideation (Score=1) | 2 | 0 |
| Suicidal Ideation with Plan (Score=3) | 0 | 0 |
Treatment acceptability was assessed using the Client Satisfaction Questionnaire (CSQ, Larsen et al., 1979). Scores range from 1-4 with scores greater than 3 representing satisfaction with the treatment.
| score on a scale | Screened Veteran | Second Partner |
|---|---|---|
| Treatment Acceptability | 3.49 ± 0.50 | 3.43 ± 0.52 |
Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).
| days of care | Screened Veteran | Second Partner |
|---|---|---|
| Number of Mental Health and Family Contacts | 3.39 ± 3.11 | 0.33 ± 0.58 |
Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).
| days of care | Screened Veteran | Second Partner |
|---|---|---|
| Number of Mental Health and Family Contacts | 4.78 ± 4.33 | 2.67 ± 3.79 |
Collected over Study duration from first to last assessment (1-3 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Screened Veteran | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Second Partner | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Event | Screened Veteran | Second Partner |
|---|---|---|
| Intimate Partner Violence EventSocial circumstances | 1/20 | 1/20 |
| Non-Suicidal Self-InjuryPsychiatric disorders | 0/20 | 0/20 |
| Suicidal BehaviorPsychiatric disorders | 0/20 | 0/20 |
This is a study of couples. Although all couples went through the same treatment, we provide separate demographics for Screened Veterans and Supporting Partners.
| Age, Continuous(years) | Screened Veteran | Supporting Partner | Total |
|---|---|---|---|
| Mean | 42.60 ± 13.68 | 41.45 ± 13.95 | 42.03 ± 13.65 |
| Sex: Female, Male(Participants) | Screened Veteran | Supporting Partner | Total |
|---|---|---|---|
| Female | 3 | 17 | 20 |
| Male | 17 | 3 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Screened Veteran | Supporting Partner | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 0 | 4 |
| Not Hispanic or Latino | 16 | 20 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Screened Veteran | Supporting Partner | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 14 | 14 | 28 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(participants) | Screened Veteran | Supporting Partner | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
| Veteran Status(Participants) | Screened Veteran | Supporting Partner | Total |
|---|---|---|---|
| Veteran | 20 | 2 | 22 |
| Non-Veteran | 0 | 18 | 18 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We will create deidentified datasets containing only variables used in a publication. This will be limited to the quantitative variables underlying publication to minimize likelihood of reidentification. Deidentified datasets will be stored in repositories if required for publication. Otherwise, they will be available on request to individual researchers with appropriate credentials.
Supporting information: Study protocol, Icf, Analytic code
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Canandaigua VA Medical Center