Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-03-01 @ 1:51 AM
Study NCT ID:
NCT02283333
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Prolonged Grief Disorder in Combat Veterans
Sponsor:
Organization:
Raw JSON
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Johnson VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for a period of 5 years, 1 month.', 'description': 'Adverse events and serious adverse events were recorded in accordance with clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'BATE-G', 'description': 'Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.\n\nBATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Treatment', 'description': 'Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.\n\nStandard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Serious Adverse Event', 'notes': 'Participant attempted suicide by attempting to overdose on blood pressure medication pills.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Inventory of Complicated Grief - Revised (ICG-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BATE-G', 'description': 'Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.\n\nBATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.'}, {'id': 'OG001', 'title': 'Standard Treatment', 'description': 'Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.\n\nStandard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.15', 'spread': '19.79', 'groupId': 'OG000'}, {'value': '93.10', 'spread': '21.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The Inventory of Complicated Grief (ICG) Revised is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. 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'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-04', 'size': 480650, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 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'2014-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inventory of Complicated Grief - Revised (ICG-R)', 'timeFrame': 'Baseline', 'description': 'The Inventory of Complicated Grief (ICG) Revised is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 50; max score 143 indicated at baseline. Higher scores indicate worse outcomes.'}, {'measure': 'Inventory of Complicated Grief - Revised (ICG-R)', 'timeFrame': '8 weeks', 'description': 'The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 33.31; max score 133 indicated at post. Higher scores indicate worse outcomes.'}, {'measure': 'Inventory of Complicated Grief - Revised (ICG-R)', 'timeFrame': '3 months', 'description': 'The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 31.97; max score 150 indicated at 3 month. Higher scores indicate worse outcomes.'}, {'measure': 'Inventory of Complicated Grief - Revised (ICG-R)', 'timeFrame': '6 months', 'description': 'The Inventory of Complicated Grief (ICG) is a self-report instrument that allows for the dimensional assessment of the severity of complicated grief symptoms. It has 34 items with scores ranging from 30 to 150. Min score 30; max score 141 indicated at 6 month. Higher scores indicate worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory - II (BDI-II)', 'timeFrame': 'Baseline', 'description': 'Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 61 indicated at baseline. Higher scores indicate worse outcomes.'}, {'measure': 'PTSD Checklist for DSM-5 (PCL 5)', 'timeFrame': 'Baseline', 'description': 'The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 2; max score 76 indicated at baseline. Higher scores indicate worse outcomes.'}, {'measure': 'Beck Depression Inventory - II (BDI-II)', 'timeFrame': '8 weeks', 'description': 'Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 58 indicated at post. Higher scores indicate worse outcomes.'}, {'measure': 'Beck Depression Inventory - II (BDI-II)', 'timeFrame': '3 months', 'description': 'Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 52 indicated at 3 month. Higher scores indicate worse outcomes.'}, {'measure': 'Beck Depression Inventory - II (BDI-II)', 'timeFrame': '6 months', 'description': 'Beck Depression Inventory-II is a 21 item measure of depressive severity with scores ranging from 0 to 63. Min score 0; max score 58 indicated at 6 month. Higher scores indicate worse outcomes.'}, {'measure': 'PTSD Checklist for DSM-5 (PCL 5)', 'timeFrame': '8 weeks', 'description': 'The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 0; max score 72 indicated at post. Higher scores indicate worse outcomes.'}, {'measure': 'PTSD Checklist for DSM-5 (PCL 5)', 'timeFrame': '3 months', 'description': 'The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 0; max score 76 indicated at 3 month. Higher scores indicate worse outcomes.'}, {'measure': 'PTSD Checklist for DSM-5 (PCL 5)', 'timeFrame': '6 months', 'description': 'The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD with scores ranging from 0 to 80. The PCL-5 has a variety of purposes, including: monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Min score 0; max score 76 indicated at 6 month. Higher scores indicate worse outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behavioral Activation', 'Therapeutic Exposure', 'Mental Health', 'Veterans', 'Complicated Grief', 'Military', 'Treatment', 'Cognitive Therapy', 'Bereavement', 'Complicated Bereavement'], 'conditions': ['Prolonged Grief Disorder']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the efficacy of an experimental treatment (termed BATE-G) for Prolonged Grief Disorder (PGD) in Veterans compared to the current, VA-approved standard of care treatment. Currently, treatments for grief in Veterans remain understudied. Our research group has recently completed pilot work on an innovative, technology-leveraged treatment protocol for PGD that combines Behavioral Activation with Therapeutic Exposure (BATE) and appears readily applicable to the Veteran and Military populations. Per the VA / DoD Iraq War Clinician Guide, 2nd ed., the current standard of treatment is Cognitive Restructuring and Supportive Grief Counseling.\n\nThe study will enroll 140 Veterans, aged 21 years and older, who served in any combat era. All Veterans will meet criteria for PGD. There will be assessments at baseline, 1 week, 3 months, and 6 months post treatment. During the treatment phase, Veterans will undergo 7 weekly sessions of either BATE-G or standard treatment. Sessions 2-6 will be delivered via televideo to the Veteran's home.\n\nWe hypothesize that BATE-G will be more effective than standard treatment in reducing symptoms of PGD, both at post-treatment and follow-up. Moreover, BATE-G will be more effective in reducing acute emotional distress and preventing long-term emotional distress in terms of general depression and anxiety symptoms. BATE-G will result in increased frequency of completed positively reinforcing, community-based events when compared to Cognitive Restructuring and Supportive Grief Counseling. BATE-G will also result in greater improvements in perceived social support and health.\n\nNote: This project is the first evidence-based treatment for PGD in military populations, thus addressing a significant service gap.", 'detailedDescription': "The 'dual burden' of (a) loss of a fellow service member in the context of (b) experiencing repeated extreme life threat is unique to military combat personnel and a core characteristic of combat-related Prolonged Grief Disorder (PGD), a disorder as prevalent as Post-traumatic stress disorder and associated with functional impairment, disability, and suicidality. Effective treatments for depression and PTSD have proven less than adequate in treating PGD when each is offered in isolation; and simply combining these 12-16 week treatment regimens into a 24-36 week treatments is not a viable approach, particularly with a population predisposed to avoiding extended mental health care. This project addresses the need for a Veteran/ military specific treatment of PGD, and uses technology to deliver this treatment in a format that is far more likely to be accepted by military personnel and Veterans. This study will impact clinical practice by providing the first evidence for effective treatment of PGD in Veterans."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants may be either Active Duty Service Personnel/Veterans of any service era.\n* Participants may be male or female,\n\n * age 21 and above,\n * with a diagnosis of Prolonged Grief Disorder.\n* Veterans starting a new psychotropic medication at baseline will be asked to wait 4 weeks for medication stabilization before starting the study.\n\nExclusion Criteria:\n\n* Actively psychotic or demented persons,\n* Individuals with both suicidal ideation and clear intent,\n* Individuals with homicidal ideation and or intent,\n* Individuals meeting criteria for substance dependence,\n* Individuals who cannot or are unwilling to schedule regular weekly appointments (with the exception of Veterans who have medical and/or transportation barriers,\n* Individuals who are already enrolled in another trial for PTSD and/or depression will be excluded.'}, 'identificationModule': {'nctId': 'NCT02283333', 'acronym': 'PGD', 'briefTitle': 'Treatment of Prolonged Grief Disorder in Combat Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Treatment of Prolonged Grief Disorder in Combat Veterans', 'orgStudyIdInfo': {'id': 'CLNA-001-14S'}, 'secondaryIdInfos': [{'id': 'CX001102', 'type': 'OTHER_GRANT', 'domain': 'VA CSR&D'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BATE-G', 'description': 'Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant.', 'interventionNames': ['Behavioral: BATE-G']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Treatment', 'description': 'Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant.', 'interventionNames': ['Behavioral: Standard Treatment']}], 'interventions': [{'name': 'BATE-G', 'type': 'BEHAVIORAL', 'description': 'Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.', 'armGroupLabels': ['BATE-G']}, {'name': 'Standard Treatment', 'type': 'BEHAVIORAL', 'description': 'Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant.', 'armGroupLabels': ['Standard Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29401-5799', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center, Charleston, SC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Ron E. Acierno, PhD MS BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, SC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}