Relationship DistressBRCNCT06011161
A Pilot of the Brief Relationship Checkup
A study testing Brief Relationship Checkup (BRC) in people with Relationship Distress, run by Canandaigua VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relationship Distress
- What is being tested?
- Brief Relationship Checkup (BRC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Finger Lakes Healthcare System (Canandaigua)
Canandaigua, New York, 14424
About this study
Official title: The Brief Relationship Checkup: A 3-Session Program to Support Veteran Relationships
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:
Read more
- 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.
Read the 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.
- Conditions
- Relationship Distress
- Being tested
- Brief Relationship Checkup (BRC)
- Keywords
- Couple therapy, Primary Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Relationship Checkup (BRC)Behavioural
Also called Marriage Checkup, Relationship Checkup
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Brief Relationship Checkup (BRC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After Completing the BRC Program (1-3months after pre-treatment)
Secondary outcomes (11)
Emotional Intimacy/Mutual Responsiveness
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.
Measured: Pre-treatment
Emotional Intimacy/Mutual Responsiveness
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After Completing the BRC Program (1-3months after pre-treatment)
Treatment Acceptability
Treatment acceptability was assessed using the Client Satisfaction Questionnaire (CSQ, Larsen et al., 1979). Scores range from 1-4 with scores greater than 3 representing satisfaction with the treatment.
Measured: After Completing the BRC Program (1-3months after pre-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start28 Jan 2020
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relationship DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot. All participants will participate in the same treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Dev J. Crasta, Canandaigua VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011161
- Sponsor's protocol ID
- 1469686
- Acronym
- BRC
- Status last verified
- Sep 2024
- First submitted
- 15 Aug 2023
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will create deidentified datasets containing only variables used in a publication. This will be limited to the quantitative variables underlying publication to minimize likelihood of reidentification. Deidentified datasets will be stored in repositories if required for publication. Otherwise, they will be available on request to individual researchers with appropriate credentials.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brief Relationship Checkup: A 3-Session Program to Support Veteran Relationships
- ClinicalTrials.gov ID
- NCT06011161
- Acronym / sponsor ID
- BRC / 1469686
- Conditions
- Relationship Distress
- Keywords
- Couple therapy, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot. All participants will participate in the same treatment.
| Arm | Type | Receives |
|---|---|---|
| Brief Relationship Checkup | Experimental | Behavioral: Brief Relationship Checkup (BRC)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Relationship Checkup (BRC)Also: Marriage Checkup, Relationship CheckupThe 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. | Behavioural | Brief Relationship Checkup |
Primary outcome
Relationship Functioning
Time frame: 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.
Relationship Functioning
Time frame: 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.
11 secondary outcomes
Emotional Intimacy/Mutual Responsiveness
Time frame: Pre-treatment
Emotional Intimacy/Mutual Responsiveness
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Depressive Symptoms
Time frame: Pre-treatment
Depressive Symptoms
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Perceived Burdensomeness
Time frame: Pre-treatment
Perceived Burdensomeness
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Thwarted Belongingness
Time frame: Pre-treatment
Thwarted Belongingness
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Suicide Ideation Severity
Time frame: Pre-treatment
Suicide Ideation Severity
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Treatment Acceptability
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will create deidentified datasets containing only variables used in a publication. This will be limited to the quantitative variables underlying publication to minimize likelihood of reidentification. Deidentified datasets will be stored in repositories if required for publication. Otherwise, they will be available on request to individual researchers with appropriate credentials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Relationship Checkup (BRC) in people with Relationship Distress, run by Canandaigua VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Functioning (time frame: Pre-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.