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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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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:
Participants completed an initial interview, attended the BRC program, and completed a follow-up interview.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Finger Lakes Healthcare System (Canandaigua) | Canandaigua | New York | 14424 | United States |
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.
Data will be available beginning one year after publication.
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.
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N/A. All participants are considered assigned to the treatment condition from the moment of couple enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Relationship Checkup | 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). 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This is a study of couples. Although all couples went through the same treatment, we provide separate demographics for Screened Veterans and Supporting Partners.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full sample | Posted | Least Squares Mean | Standard Error | score on a scale | Pre-treatment |
|
Study duration from first to last assessment (1-3 months).
In addition to non-systematic assessment of adverse events broadly used by the (i.e., untoward or unfavorable medical occurrence in a participant), we also used systematic assessments to monitor for any intimate partner violence, self-harm, or suicidal behavior from first visit to last visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intimate Partner Violence Event | Social circumstances | Systematic Assessment | Occurrence of physical conflict behavior even if it does not lead to medical complications. Our single violence event is marked as a negative event for both partners in the couple. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dev Crasta | VISN 2 Center of Excellence for Suicide Prevention | 585-364-8119 | Dev.Crasta@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2021 | Apr 11, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2020 | Aug 15, 2023 | ICF_000.pdf |
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Single arm pilot. All participants will participate in the same treatment.
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| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After Completing the BRC Program (1-3months after pre-treatment) |
| 90 day period before pre-treatment session |
| 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 final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Veteran Status | Count of Participants | Participants |
|
| OG001 | Second Partner | This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short. |
|
|
| 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. | Participants completing the measure at follow-up. | Posted | Least Squares Mean | Standard Error | score on a scale | 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 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. | Whole sample | Posted | Least Squares Mean | Standard Error | score on a scale | Pre-treatment |
|
|
|
| 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). | Participants completing the measure at follow-up. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Full sample | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Participants completing the measure at follow-up. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | All participants completing measure at baseline. Two participants missing data as measure is on last page. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | All participants completing measure at baseline. Two participants missing data as measure is on last page. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | Participants completing the measure at follow-up. | Posted | Least Squares Mean | Standard Error | score on a scale | 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. | All participants | Posted | Count of Participants | Participants | 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. | Participants who completed as C-SSRS interview. | Posted | Count of Participants | Participants | After Completing the BRC Program (1-3months after pre-treatment) |
|
|
|
| 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. | All participants completing the follow-up survey. | Posted | Mean | Standard Deviation | score on a scale | After Completing the BRC Program (1-3months after pre-treatment) |
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| 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). | Participants who completed treatment and had accessible charts in the VA medical record | Posted | Mean | Standard Deviation | days of care | 90 day period before pre-treatment session |
|
|
|
| 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). | Participants who completed treatment and had accessible charts in the VA medical record | Posted | Mean | Standard Deviation | days of care | 90 day period after final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Second Partner | This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short. | 0 | 20 | 0 | 20 | 1 | 20 |
|
| Non-Suicidal Self-Injury | Psychiatric disorders | Systematic Assessment | Any form of intentional self-injury without suicidal intent, even if it does not lead to medical consequences or hospitalization. |
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| Suicidal Behavior | Psychiatric disorders | Non-systematic Assessment | Any suicidal attempt, self/other interrupted attempt, or preparatory behavior even if it does not result in hospitalization or medical consequences . |
|
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| Ideation with Plan (Score=3) |
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| Suicidal Ideation with Plan (Score=3) |
|