Clinical trial NCT06011161: A Pilot of the Brief Relationship Checkup
Official title: The Brief Relationship Checkup: A 3-Session Program to Support Veteran Relationships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relationship Distress
Keywords: Couple therapy
Primary Care
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2023-08-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot. All participants will participate in the same treatment.
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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., 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)

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.

Primary outcomes:
measure: Relationship Functioning
timeFrame: Pre-treatment
measure: Relationship Functioning
timeFrame: After Completing the BRC Program (1-3months after pre-treatment)
Secondary outcomes:
measure: Emotional Intimacy/Mutual Responsiveness
timeFrame: Pre-treatment
measure: Emotional Intimacy/Mutual Responsiveness
timeFrame: After Completing the BRC Program (1-3months after pre-treatment)
measure: Depressive Symptoms
timeFrame: Pre-treatment
measure: Depressive Symptoms
timeFrame: After Completing the BRC Program (1-3months after pre-treatment)
measure: Perceived Burdensomeness
timeFrame: Pre-treatment
measure: Perceived Burdensomeness
timeFrame: After Completing the BRC Program (1-3months after pre-treatment)
measure: Thwarted Belongingness
timeFrame: Pre-treatment
measure: Thwarted Belongingness
timeFrame: After Completing the BRC Program (1-3months after pre-treatment)
measure: Suicide Ideation Severity
timeFrame: Pre-treatment
measure: Suicide Ideation Severity
timeFrame: After Completing the BRC Program (1-3months after pre-treatment)
measure: Treatment Acceptability
timeFrame: After Completing the BRC Program (1-3months after pre-treatment)
Other outcomes:
measure: Number of Mental Health and Family Contacts
timeFrame: 90 day period before pre-treatment session
measure: Number of Mental Health and Family Contacts
timeFrame: 90 day period after final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo)
Locations:
city: Canandaigua
country: United States
facility: Finger Lakes Healthcare System (Canandaigua)
state: New York
Study officials:
References: