A Pilot of the Brief Relationship Checkup

NCT06011161 | Completed Results

• 1 other identifier: 1469686
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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:

1. 1.Can the research team deliver BRC to Veterans with mental health concerns? ("Feasibility")
2. 2.What is the best way to measure BRC's impact? ("Pilot Outcomes")
3. 3.Does BRC fit the needs of Veterans, and if not, what changes would fit participants' needs? ("Refinement")

Conditions

Relationship Distress

Keywords

Couple therapy; Primary Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Emotional Intimacy/Mutual Responsiveness

  Pre-treatment

• Emotional Intimacy/Mutual Responsiveness

  After Completing the BRC Program (1-3months after pre-treatment)

• Depressive Symptoms

  Pre-treatment

• Depressive Symptoms

  After Completing the BRC Program (1-3months after pre-treatment)

• Perceived Burdensomeness

  Pre-treatment

Other Outcomes (2)

• Number of Mental Health and Family Contacts

  90 day period before pre-treatment session

• Number of Mental Health and Family Contacts

  90 day period after final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo)

Study Arms (1)

Brief Relationship Checkup

EXPERIMENTAL

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)

Interventions

Brief Relationship Checkup (BRC) BEHAVIORAL

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

Brief Relationship Checkup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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., Patient Health Questionnaire(PHQ)-2 for Depression, PHQ Item 9 for Suicide Risk; Alcohol Use Disorders Identification Test Consumption Questions for At-Risk Drinking; or Primary Care-PTSD-5 for Potential PTSD)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canandaigua VA Medical Center: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Finger Lakes Healthcare System (Canandaigua)

Canandaigua, New York, 14424, United States

Location

Limitations and Caveats

This study is a small pilot without a comparison group and half of the Screened Veterans were participating in individual therapy. Therefore, it is possible that some of these couples may have been expected to naturally improve over time, and it is unclear how much of the improvements seen in this ClinicalTrials.gov registration are due to the treatment itself.

Results Point of Contact

• Title: Dev Crasta
• Organization: VISN 2 Center of Excellence for Suicide Prevention

Dev.Crasta@va.gov

585-364-8119

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm pilot. All participants will participate in the same treatment.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 25, 2023
• Study Start: January 28, 2020
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning one year after publication.
• Access Criteria: Researchers must demonstrate they are accessing the data for validation of results or other scientific/public purposes (e.g., replication of findings, incorporation of findings in meta-analyses). Data sets will not be shared prior to the facility Privacy Officer approval of the access request and deidentification steps.

Locations

US (1)