Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT01624935
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2012-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079062', 'term': 'Interpersonal Psychotherapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-30', 'studyFirstSubmitDate': '2012-02-07', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Administered PTSD Scale (CAPS)', 'timeFrame': 'baseline through week 24', 'description': 'CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24'}], 'secondaryOutcomes': [{'measure': 'Standard Clinical Interview for DSM IV Diagnosis (SCID)', 'timeFrame': 'baseline through week 24', 'description': 'CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTSD', 'earthquake', 'disaster', 'global mental health', 'disaster mental health', 'depression'], 'conditions': ['Posttraumatic Stress Disorder', 'Depression']}, 'referencesModule': {'references': [{'pmid': '25254070', 'type': 'DERIVED', 'citation': 'Jiang RF, Tong HQ, Delucchi KL, Neylan TC, Shi Q, Meffert SM. Interpersonal psychotherapy versus treatment as usual for PTSD and depression among Sichuan earthquake survivors: a randomized clinical trial. Confl Health. 2014 Sep 4;8:14. doi: 10.1186/1752-1505-8-14. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.\n\nHypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.\n\nHypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.', 'detailedDescription': 'Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years;\n* diagnosis with Depressive Disorder and Posttraumatic Stress Disorder (PTSD);\n* Ability to attend weekly therapy sessions for 12 weeks and return for post-treatment screening;\n* Ability to give verbal informed consent\n\nExclusion Criteria:\n\n* Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;\n* Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;\n* drug and alcohol dependence'}, 'identificationModule': {'nctId': 'NCT01624935', 'briefTitle': 'Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake', 'orgStudyIdInfo': {'id': '10-02408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'psychotherapy', 'description': 'psychotherapy', 'interventionNames': ['Behavioral: interpersonal psychotherapy']}, {'type': 'OTHER', 'label': 'treatment as usual', 'description': 'TAU control', 'interventionNames': ['Behavioral: interpersonal psychotherapy']}], 'interventions': [{'name': 'interpersonal psychotherapy', 'type': 'BEHAVIORAL', 'description': 'interpersonal psychotherapy', 'armGroupLabels': ['psychotherapy', 'treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fangting', 'state': 'Sichuan', 'country': 'China', 'facility': 'Wuhan Hospital for Psychotherapy', 'geoPoint': {'lat': 31.12766, 'lon': 104.16649}}], 'overallOfficials': [{'name': 'Susan Meffert, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}