Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT00081367
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2004-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community-Based Cognitive Therapy for Suicide Attempters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-09', 'studyFirstSubmitDate': '2004-04-09', 'studyFirstSubmitQcDate': '2004-04-09', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeat suicide attempts', 'timeFrame': 'Measured during treatment and 1, 3, 6, 12, 18, and 24 months after study completion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Minority Groups'], 'conditions': ['Suicide, Attempted']}, 'referencesModule': {'references': [{'pmid': '16077050', 'type': 'BACKGROUND', 'citation': 'Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.'}, {'pmid': '33884617', 'type': 'DERIVED', 'citation': 'Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of cognitive behavioral therapy (CBT) in preventing future suicide attempts in repeat suicide attempters.', 'detailedDescription': 'Rates of mental health and substance use disorders are high among economically disadvantaged, ethnic minority populations. Studies have shown that CBT designed for this high-risk population is successful at reducing suicide attempts in people with suicidal thoughts or attempts. This study will implement a CBT intervention into the community and will focus on increasing compliance with psychiatric, substance abuse, and medical treatment.\n\nParticipants in this study will be randomly assigned to receive either CBT plus standard care or standard care alone. Participants who receive CBT will have ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed. Assessments will be made 1, 3, 6, 12, 18, and 24 months after study completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suicide attempt within 48 hours prior to being evaluated at the hospital\n* English speaking\n* Able to provide 2 verifiable contacts\n\nExclusion Criteria:\n\n* Acute, unstable, or severe Axis III disorder or a severe Axis I disorder that may prevent safe participation in outpatient psychotherapy'}, 'identificationModule': {'nctId': 'NCT00081367', 'briefTitle': 'Community-Based Cognitive Therapy for Suicide Attempters', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Community-Based Cognitive Therapy for Suicide Attempters', 'orgStudyIdInfo': {'id': 'R01MH067805', 'link': 'https://reporter.nih.gov/quickSearch/R01MH067805', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH067805', 'link': 'https://reporter.nih.gov/quickSearch/R01MH067805', 'type': 'NIH'}, {'id': 'DSIR 83-ATP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive behavioral therapy (CBT) + standard care', 'description': 'Participants will receive ten weekly sessions of treatment plus standard care for suicide prevention.', 'interventionNames': ['Behavioral: CBT', 'Behavioral: Standard care alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care alone', 'description': 'Participants will receive standard care for suicide prevention.', 'interventionNames': ['Behavioral: Standard care alone']}], 'interventions': [{'name': 'CBT', 'type': 'BEHAVIORAL', 'description': 'Participants will receive ten weekly sessions of treatment. Suicidal thoughts or attempts, hopelessness, depression, health care utilization, and overall psychological and social adaptation will be assessed.', 'armGroupLabels': ['Cognitive behavioral therapy (CBT) + standard care']}, {'name': 'Standard care alone', 'type': 'BEHAVIORAL', 'description': 'Participants will receive standard care for suicide prevention.', 'armGroupLabels': ['Cognitive behavioral therapy (CBT) + standard care', 'Standard care alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor of Clinical Psychology in Psychiatry', 'investigatorFullName': 'Gregory Brown', 'investigatorAffiliation': 'University of Pennsylvania'}}}}