18 and older, any sex, with Relationship Distress. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Relationship FunctioningPrimary· Pre-treatment
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.
Group
Value
95% CI
Screened Veteran
84.99
± 6.60
Second Partner
90.90
± 6.60
Relationship FunctioningPrimary· After Completing the BRC Program (1-3months after pre-treatment)
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.
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.
Group
Value
95% CI
Screened Veteran
41.64
± 4.49
Second Partner
44.80
± 4.49
Emotional Intimacy/Mutual ResponsivenessSecondary· After Completing the BRC Program (1-3months after pre-treatment)
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).
Group
Value
95% CI
Screened Veteran
58.87
± 4.65
Second Partner
50.67
± 4.61
Depressive SymptomsSecondary· Pre-treatment
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.
Group
Value
95% CI
Screened Veteran
11.00
± 0.98
Second Partner
7.50
± 0.98
Depressive SymptomsSecondary· After Completing the BRC Program (1-3months after pre-treatment)
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.
Group
Value
95% CI
Screened Veteran
8.17
± 1.08
Second Partner
4.24
± 1.06
Perceived BurdensomenessSecondary· Pre-treatment
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.
Group
Value
95% CI
Screened Veteran
11.14
± 1.05
Second Partner
7.84
± 1.07
Perceived BurdensomenessSecondary· After Completing the BRC Program (1-3months after pre-treatment)
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.
Group
Value
95% CI
Screened Veteran
9.76
± 1.09
Second Partner
7.06
± 1.09
Thwarted BelongingnessSecondary· Pre-treatment
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.
Group
Value
95% CI
Screened Veteran
31.26
± 2.43
Second Partner
28.32
± 2.47
Thwarted BelongingnessSecondary· After Completing the BRC Program (1-3months after pre-treatment)
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.
Group
Value
95% CI
Screened Veteran
23.75
± 2.55
Second Partner
23.50
± 2.55
Suicide Ideation SeveritySecondary· Pre-treatment
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.
Group
Value
95% CI
Screened Veteran
18
Second Partner
20
Screened Veteran
1
Second Partner
0
Screened Veteran
1
Second Partner
0
Suicide Ideation SeveritySecondary· After Completing the BRC Program (1-3months after pre-treatment)
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.
Group
Value
95% CI
Screened Veteran
14
Second Partner
17
Screened Veteran
2
Second Partner
0
Screened Veteran
0
Second Partner
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Study duration from first to last assessment (1-3 months)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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:
1. Can the research team deliver BRC to Veterans with mental health concerns? ("Feasibility")
2. What is the best way to measure BRC's impact? ("Pilot Outcomes")
3. Does BRC fit the needs of Veterans, and if not, what changes would fit participants' needs? ("Refinement")
Participants completed an initial interview, attended the BRC program, and completed a follow-up interview.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Canandaigua VA Medical Center
Last refreshed: 1 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06011161.