Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT06011161
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2023-08-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot of the Brief Relationship Checkup
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dev.Crasta@va.gov', 'phone': '585-364-8119', 'title': 'Dev Crasta', 'organization': 'VISN 2 Center of Excellence for Suicide Prevention'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'Study duration from first to last assessment (1-3 months).', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Screened Veteran', 'description': '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.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Second Partner', 'description': '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.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intimate Partner Violence Event', 'notes': '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.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Suicidal Self-Injury', 'notes': 'Any form of intentional self-injury without suicidal intent, even if it does not lead to medical consequences or hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Behavior', 'notes': 'Any suicidal attempt, self/other interrupted attempt, or preparatory behavior even if it does not result in hospitalization or medical consequences .', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relationship Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.99', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '90.90', 'spread': '6.60', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-treatment', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full sample'}, {'type': 'PRIMARY', 'title': 'Relationship Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '117.66', 'spread': '6.97', 'groupId': 'OG000'}, {'value': '106.81', 'spread': '6.88', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the measure at follow-up.'}, {'type': 'SECONDARY', 'title': 'Emotional Intimacy/Mutual Responsiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.64', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '44.80', 'spread': '4.49', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-treatment', 'description': '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.\n\nThe PRI has a minimum of 0 and a maximum of 80, with higher scores indicating greater sense of validation/understanding from one\'s partner.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Whole sample'}, {'type': 'SECONDARY', 'title': 'Emotional Intimacy/Mutual Responsiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.87', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '50.67', 'spread': '4.61', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.\n\nThe 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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the measure at follow-up.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.00', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-treatment', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full sample'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.17', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '4.24', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the measure at follow-up.'}, {'type': 'SECONDARY', 'title': 'Perceived Burdensomeness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.14', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '7.84', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-treatment', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing measure at baseline. Two participants missing data as measure is on last page.'}, {'type': 'SECONDARY', 'title': 'Perceived Burdensomeness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.76', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '7.06', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Thwarted Belongingness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.26', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '28.32', 'spread': '2.47', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-treatment', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing measure at baseline. Two participants missing data as measure is on last page.'}, {'type': 'SECONDARY', 'title': 'Thwarted Belongingness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.75', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '23.50', 'spread': '2.55', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the measure at follow-up.'}, {'type': 'SECONDARY', 'title': 'Suicide Ideation Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'title': 'No ideation (Score=0)', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Passive Death Ideation (Score=1)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Ideation with Plan (Score=3)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-treatment', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Suicide Ideation Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'title': 'No Ideation (Score=0)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Passive Death Ideation (Score=1)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Suicidal Ideation with Plan (Score=3)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed as C-SSRS interview.'}, {'type': 'SECONDARY', 'title': 'Treatment Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.49', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completing the follow-up survey.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Mental Health and Family Contacts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.39', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 day period before pre-treatment session', 'description': '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).', 'unitOfMeasure': 'days of care', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed treatment and had accessible charts in the VA medical record'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Mental Health and Family Contacts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'OG001', 'title': 'Second Partner', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.78', 'spread': '4.33', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '3.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 day period after final treatment session (earliest window 1-4mo after pre-treatment session and latest window 3-6mo)', 'description': '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).', 'unitOfMeasure': 'days of care', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed treatment and had accessible charts in the VA medical record'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brief Relationship Checkup', 'description': '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).\n\nBrief 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'N/A. All participants are considered assigned to the treatment condition from the moment of couple enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Screened Veteran', 'description': '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.'}, {'id': 'BG001', 'title': 'Supporting Partner', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.60', 'spread': '13.68', 'groupId': 'BG000'}, {'value': '41.45', 'spread': '13.95', 'groupId': 'BG001'}, {'value': '42.03', 'spread': '13.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Veteran Status', 'classes': [{'categories': [{'title': 'Veteran', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Non-Veteran', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This is a study of couples. Although all couples went through the same treatment, we provide separate demographics for Screened Veterans and Supporting Partners.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-01', 'size': 493507, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-11T09:05', 'hasProtocol': True}, {'date': '2020-03-27', 'size': 368783, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-15T15:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm pilot. All participants will participate in the same treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2023-08-15', 'resultsFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-26', 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Mental Health and Family Contacts', 'timeFrame': '90 day period before pre-treatment session', 'description': '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).'}, {'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)', 'description': '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).'}], 'primaryOutcomes': [{'measure': 'Relationship Functioning', 'timeFrame': 'Pre-treatment', 'description': '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.'}, {'measure': 'Relationship Functioning', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Emotional Intimacy/Mutual Responsiveness', 'timeFrame': 'Pre-treatment', 'description': '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.\n\nThe 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': 'Emotional Intimacy/Mutual Responsiveness', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.\n\nThe 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).'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'Pre-treatment', 'description': '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.'}, {'measure': 'Depressive Symptoms', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.'}, {'measure': 'Perceived Burdensomeness', 'timeFrame': 'Pre-treatment', 'description': '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.'}, {'measure': 'Perceived Burdensomeness', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.'}, {'measure': 'Thwarted Belongingness', 'timeFrame': 'Pre-treatment', 'description': '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.'}, {'measure': 'Thwarted Belongingness', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.'}, {'measure': 'Suicide Ideation Severity', 'timeFrame': 'Pre-treatment', 'description': '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.'}, {'measure': 'Suicide Ideation Severity', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.'}, {'measure': 'Treatment Acceptability', 'timeFrame': 'After Completing the BRC Program (1-3months after pre-treatment)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Couple therapy', 'Primary Care'], 'conditions': ['Relationship Distress']}, 'descriptionModule': {'briefSummary': '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.\n\nBRC 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:\n\n1. Can the research team deliver BRC to Veterans with mental health concerns? ("Feasibility")\n2. What is the best way to measure BRC\'s impact? ("Pilot Outcomes")\n3. Does BRC fit the needs of Veterans, and if not, what changes would fit participants\' needs? ("Refinement")\n\nParticipants completed an initial interview, attended the BRC program, and completed a follow-up interview.', 'detailedDescription': '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.\n\nRESEARCH 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.\n\nSPECIFIC AIMS:\n\nAIM 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.\n\nAIM 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.\n\nAIM 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. BOTH PARTNERS must be age 18 or over\n2. BOTH PARTNERS must demonstrate sufficient knowledge of English and cognitive capacity to understand the study through comprehension of consent questions\n3. BOTH PARTNERS must self-identify as "in a committed relationship" with their partner for at least 6-months.\n4. AT LEAST ONE PARTNER must report at least mild relationship distress on a satisfaction screen.\n5. AT LEAST ONE PARTNER must have Veteran status\n6. 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)\n\nExclusion Criteria:\n\n1. EITHER PARTNER reports that they are engaged in ongoing couple or family therapy.\n2. EITHER PARTNER reports severe intimate partner violence in the last year.\n3. EITHER PARTNER reports experiencing suicidal intent or suicidal attempts in the last month.\n4. EITHER PARTNER experiences current psychosis.\n5. EITHER PARTNER experiences current mania.'}, 'identificationModule': {'nctId': 'NCT06011161', 'acronym': 'BRC', 'briefTitle': 'A Pilot of the Brief Relationship Checkup', 'organization': {'class': 'FED', 'fullName': 'Canandaigua VA Medical Center'}, 'officialTitle': 'The Brief Relationship Checkup: A 3-Session Program to Support Veteran Relationships', 'orgStudyIdInfo': {'id': '1469686'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief Relationship Checkup', 'description': '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).', 'interventionNames': ['Behavioral: Brief Relationship Checkup (BRC)']}], 'interventions': [{'name': 'Brief Relationship Checkup (BRC)', 'type': 'BEHAVIORAL', 'otherNames': ['Marriage Checkup', 'Relationship Checkup'], 'description': '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.', 'armGroupLabels': ['Brief Relationship Checkup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14424', 'city': 'Canandaigua', 'state': 'New York', 'country': 'United States', 'facility': 'Finger Lakes Healthcare System (Canandaigua)', 'geoPoint': {'lat': 42.87423, 'lon': -77.28804}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available beginning one year after publication.', 'ipdSharing': 'YES', 'description': '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.\n\nDeidentified datasets will be stored in repositories if required for publication. Otherwise, they will be available on request to individual researchers with appropriate credentials.', 'accessCriteria': '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).\n\nData sets will not be shared prior to the facility Privacy Officer approval of the access request and deidentification steps.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canandaigua VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dev J. Crasta', 'investigatorAffiliation': 'Canandaigua VA Medical Center'}}}}