Relationship Distress
Conditions
Keywords
Couple therapy, Primary Care
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.
Interventions
BEHAVIORALBrief 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.
Sponsors
US Department of Veterans Affairs
Canandaigua VA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm pilot. All participants will participate in the same treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Functioning | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Intimacy/Mutual Responsiveness | Pre-treatment | 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. |
| Depressive Symptoms | Pre-treatment | 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. |
| Perceived Burdensomeness | Pre-treatment | 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. |
| Suicide Ideation Severity | Pre-treatment | 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. |
| Treatment Acceptability | After Completing the BRC Program (1-3months after pre-treatment) | 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. |
| Thwarted Belongingness | Pre-treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Mental Health and Family Contacts | 90 day period before pre-treatment session | 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). |
Countries
United States
Participant flow
Pre-assignment details
N/A. All participants are considered assigned to the treatment condition from the moment of couple enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Screened Veteran This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as VA-engaged Veterans, Identified Patients, or Patients for short. | 20 |
| Supporting Partner This is the second partner that is referred to the study. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we refer to those participants as Second Partners or simply Partners for short. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Supporting Partner | Total | Screened Veteran |
|---|---|---|---|
| Age, Continuous | 41.45 years STANDARD_DEVIATION 13.95 | 42.03 years STANDARD_DEVIATION 13.65 | 42.60 years STANDARD_DEVIATION 13.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 36 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 20 Participants | 17 Participants |
| Veteran Status Non-Veteran | 18 Participants | 18 Participants | 0 Participants |
| Veteran Status Veteran | 2 Participants | 22 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Population: Participants completing the measure at follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Relationship Functioning | 117.66 score on a scale | Standard Error 6.97 |
| Second Partner | Relationship Functioning | 106.81 score on a scale | Standard Error 6.88 |
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.
Time frame: Pre-treatment
Population: Full sample
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Relationship Functioning | 84.99 score on a scale | Standard Error 6.6 |
| Second Partner | Relationship Functioning | 90.90 score on a scale | Standard Error 6.6 |
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.
Time frame: Pre-treatment
Population: Full sample
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Depressive Symptoms | 11.00 score on a scale | Standard Error 0.98 |
| Second Partner | Depressive Symptoms | 7.50 score on a scale | Standard Error 0.98 |
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.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Population: Participants completing the measure at follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Depressive Symptoms | 8.17 score on a scale | Standard Error 1.08 |
| Second Partner | Depressive Symptoms | 4.24 score on a scale | Standard Error 1.06 |
Secondary
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.
Time frame: Pre-treatment
Population: Whole sample
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Emotional Intimacy/Mutual Responsiveness | 41.64 score on a scale | Standard Error 4.49 |
| Second Partner | Emotional Intimacy/Mutual Responsiveness | 44.80 score on a scale | Standard Error 4.49 |
Secondary
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).
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Population: Participants completing the measure at follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Emotional Intimacy/Mutual Responsiveness | 58.87 score on a scale | Standard Error 4.65 |
| Second Partner | Emotional Intimacy/Mutual Responsiveness | 50.67 score on a scale | Standard Error 4.61 |
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.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Population: All participants completing the measure at follow-up, with the exception of two screened Veterans who reported a 10-point reduction in burdensomeness who were removed from analysis in order to create a conservative estimate of reduction.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Perceived Burdensomeness | 9.76 score on a scale | Standard Error 1.09 |
| Second Partner | Perceived Burdensomeness | 7.06 score on a scale | Standard Error 1.09 |
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.
Time frame: Pre-treatment
Population: All participants completing measure at baseline. Two participants missing data as measure is on last page.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Perceived Burdensomeness | 11.14 score on a scale | Standard Error 1.05 |
| Second Partner | Perceived Burdensomeness | 7.84 score on a scale | Standard Error 1.07 |
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.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Population: Participants who completed as C-SSRS interview.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screened Veteran | Suicide Ideation Severity | No Ideation (Score=0) | 14 Participants |
| Screened Veteran | Suicide Ideation Severity | Passive Death Ideation (Score=1) | 2 Participants |
| Screened Veteran | Suicide Ideation Severity | Suicidal Ideation with Plan (Score=3) | 0 Participants |
| Second Partner | Suicide Ideation Severity | No Ideation (Score=0) | 17 Participants |
| Second Partner | Suicide Ideation Severity | Passive Death Ideation (Score=1) | 0 Participants |
| Second Partner | Suicide Ideation Severity | Suicidal Ideation with Plan (Score=3) | 0 Participants |
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.
Time frame: Pre-treatment
Population: All participants
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screened Veteran | Suicide Ideation Severity | No ideation (Score=0) | 18 Participants |
| Screened Veteran | Suicide Ideation Severity | Passive Death Ideation (Score=1) | 1 Participants |
| Screened Veteran | Suicide Ideation Severity | Ideation with Plan (Score=3) | 1 Participants |
| Second Partner | Suicide Ideation Severity | No ideation (Score=0) | 20 Participants |
| Second Partner | Suicide Ideation Severity | Passive Death Ideation (Score=1) | 0 Participants |
| Second Partner | Suicide Ideation Severity | Ideation with Plan (Score=3) | 0 Participants |
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.
Time frame: Pre-treatment
Population: All participants completing measure at baseline. Two participants missing data as measure is on last page.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Thwarted Belongingness | 31.26 score on a scale | Standard Error 2.43 |
| Second Partner | Thwarted Belongingness | 28.32 score on a scale | Standard Error 2.47 |
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.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Population: Participants completing the measure at follow-up.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Thwarted Belongingness | 23.75 score on a scale | Standard Error 2.55 |
| Second Partner | Thwarted Belongingness | 23.50 score on a scale | Standard Error 2.55 |
Secondary
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.
Time frame: After Completing the BRC Program (1-3months after pre-treatment)
Population: All participants completing the follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Treatment Acceptability | 3.49 score on a scale | Standard Deviation 0.5 |
| Second Partner | Treatment Acceptability | 3.43 score on a scale | Standard Deviation 0.52 |
Other Pre-specified
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).
Time frame: 90 day period after final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo)
Population: Participants who completed treatment and had accessible charts in the VA medical record
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Number of Mental Health and Family Contacts | 4.78 days of care | Standard Deviation 4.33 |
| Second Partner | Number of Mental Health and Family Contacts | 2.67 days of care | Standard Deviation 3.79 |
Other Pre-specified
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).
Time frame: 90 day period before pre-treatment session
Population: Participants who completed treatment and had accessible charts in the VA medical record
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Veteran | Number of Mental Health and Family Contacts | 3.39 days of care | Standard Deviation 3.11 |
| Second Partner | Number of Mental Health and Family Contacts | 0.33 days of care | Standard Deviation 0.58 |