Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-04 @ 10:53 PM
Study NCT ID:
NCT03803332
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2019-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000094964', 'term': 'Military Sexual Trauma'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000082002', 'term': 'Sexual Trauma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007171', 'term': 'Implosive Therapy'}, {'id': 'D000079062', 'term': 'Interpersonal Psychotherapy'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment', 'timeFrame': 'Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition', 'description': 'The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity'}, {'measure': 'Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group', 'timeFrame': 'Baseline, 11 weeks', 'description': 'The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity'}, {'measure': 'Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group', 'timeFrame': 'Baseline, 15 weeks', 'description': 'The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'Military Sexual Trauma', 'exposure therapy', 'interpersonal psychotherapy', 'treatment'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as many people as possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English-speaking\n* Military Sexual Trauma (MST) survivors, with MST defined as actual or threatened sexual violence, from Vietnam era to current Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn\n* Diagnosed with PTSD consequent to MST, with a minimum CAPS score \\> 40\n* Medically stable at time of study enrollment (for persons with chronic injuries and that any disability present does not prevent attendance of weekly outpatient therapy sessions)\n* Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments\n* Stable on psychotropic medication for the prior 60 days\n\nExclusion Criteria:\n\n* Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder\n* Participation in a clinical trial or concurrent evidence-based treatment for MST-related psychiatric conditions or PTSD during the previous 3 months\n* Current evidence of significant unstable medical illness or organic brain impairment such that the patient could not attend sessions regularly or complete assessments\n* Patients who in the investigator's judgment pose a current homicidal or suicidal risk\n* Current or history of substance dependence in the past 90 days."}, 'identificationModule': {'nctId': 'NCT03803332', 'briefTitle': 'A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma', 'orgStudyIdInfo': {'id': '1409015511'}, 'secondaryIdInfos': [{'id': 'W81XWH-16-R-BAA1', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exposure Therapy', 'description': 'Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.', 'interventionNames': ['Behavioral: Exposure Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interpersonal Psychotherapy', 'description': 'Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.', 'interventionNames': ['Behavioral: Interpersonal Psychotherapy']}], 'interventions': [{'name': 'Exposure Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Prolonged Exposure'], 'description': 'Psychotherapy including imaginal and in vivo exposure for PTSD.', 'armGroupLabels': ['Exposure Therapy']}, {'name': 'Interpersonal Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.', 'armGroupLabels': ['Interpersonal Psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olivia Baryluk, BS', 'role': 'CONTACT', 'email': 'olb4002@med.cornell.edu', 'phone': '212-821-0783'}], 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Olivia Baryluk, BS', 'role': 'CONTACT', 'email': 'olb4002@med.cornell.edu', 'phone': '212-821-0783'}], 'overallOfficials': [{'name': 'JoAnn Difede, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}