A Pilot of the Brief Relationship Checkup

Relationship Distress Clinical Trial

— BRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011161
• Other study ID #: 1469686
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: July 20, 2021

Study information

• Verified date: August 2023
• Source: Canandaigua VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. BOTH PARTNERS must be age 18 or over

2. BOTH PARTNERS must demonstrate sufficient knowledge of English and cognitive capacity to understand the study through comprehension of consent questions

3. BOTH PARTNERS must self-identify as "in a committed relationship" with their partner for at least 6-months.

4. AT LEAST ONE PARTNER must report at least mild relationship distress on a satisfaction screen.

5. AT LEAST ONE PARTNER must have Veteran status

6. 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:

1. EITHER PARTNER reports that they are engaged in ongoing couple or family therapy.

2. EITHER PARTNER reports severe intimate partner violence in the last year.

3. EITHER PARTNER reports experiencing suicidal intent or suicidal attempts in the last month.

4. EITHER PARTNER experiences current psychosis.

5. EITHER PARTNER experiences current mania.

Related Conditions & MeSH terms

• Relationship Distress

Intervention

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.

Locations

Country	Name	City	State
United States	Finger Lakes Healthcare System (Canandaigua)	Canandaigua	New York

Sponsors (2)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	90 day period before treatment
Other	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).	90 day period after treatment
Primary	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
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)