A Pilot of the Brief Relationship Checkup

Study Overview
=================
Brief Summary
-----------------
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: Can the research team deliver BRC to Veterans with mental health concerns? (Feasibility) What is the best way to measure BRC's impact? (Pilot Outcomes) 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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Brief Relationship Checkup: A 3-Session Program to Support Veteran Relationships

Conditions
-----------------
Relationship Distress

Intervention / Treatment
-----------------
* Behavioral: Brief Relationship Checkup (BRC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BOTH PARTNERS must be age 18 or over BOTH PARTNERS must demonstrate sufficient knowledge of English and cognitive capacity to understand the study through comprehension of consent questions BOTH PARTNERS must self-identify as in a committed relationship with their partner for at least 6-months. AT LEAST ONE PARTNER must report at least mild relationship distress on a satisfaction screen. AT LEAST ONE PARTNER must have Veteran status THE VETERAN PARTNER must screen positive on at least on a VA Primary Care Mental Health Screen (i.e., PHQ-2 for Depression, PHQ Item 9 for Suicide Risk; AUDIT Consumption Questions for At-Risk Drinking; or PC-PTSD-5 for Potential PTSD) Exclusion Criteria: EITHER PARTNER reports that they are engaged in ongoing couple or family therapy. EITHER PARTNER reports severe intimate partner violence in the last year. EITHER PARTNER reports experiencing suicidal intent or suicidal attempts in the last month. EITHER PARTNER experiences current psychosis. EITHER PARTNER experiences current mania.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot. All participants will participate in the same treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Relationship Checkup<br>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)<br>* 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.<br>* Other names: Relationship Checkup;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | After Completing the BRC Program (1-3months after pre-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Intimacy/Mutual Responsiveness | Emotional Intimacy will be measured using the Perceived Responsiveness & Insensitivity Scale (PRI). The PRI has a minimum of 0 and a maximum of 80. 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/caring. | Pre-treatment | 
| Emotional Intimacy/Mutual Responsiveness | Emotional Intimacy will be measured using the Perceived Responsiveness & Insensitivity Scale (PRI). The PRI has a minimum of 0 and a maximum of 80. 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/caring. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After Completing the BRC Program (1-3months after pre-treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Couple therapy, Primary Care