Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT02777294
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Web-Based CBT for Rape Victims
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PTSD symptoms (PTSD Symptom Scale Interview)', 'timeFrame': 'Change in PTSD symptoms from baseline to 3 months post intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['PTSD']}, 'referencesModule': {'references': [{'pmid': '37795783', 'type': 'DERIVED', 'citation': "O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2."}]}, 'descriptionModule': {'briefSummary': 'Rape is unfortunately a common experience among women, affecting between 13 and 20%. In addition, up to 50% of all rape victims experience significant and persistent psychological distress. While cognitive-behavioral interventions have been found to be successful at alleviating distress among victims; the majority do not seek out these services, often because of feelings of stigma and self-blame. One potential method for circumventing these barriers is through online administered treatment. Thus, the current project is designed to conduct an initial evaluation of a 12 to 16-week, therapist-facilitated, multi-media, cognitive-behavioral, online intervention tailored specifically for rape victims. The effectiveness of this program at ameliorating distress among college women who have experienced rape and have current posttraumatic stress disorder (PTSD) was evaluated. Reductions in psychological distress was the primary outcome and was assessed at post-intervention and at three and six month follow-up periods. The effectiveness of the intervention was compared to a psycho-educational website.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current rape-related PTSD\n* Regular access to a computer\n* English language literacy\n* Experience of completed rape at age 14 years or older\n\nExclusion Criteria:\n\n* No current PTSD\n* Current psychotherapy\n* Lack of stability on psychotropic medication (\\< 3 months)\n* Lack of literacy in English\n* Current substance dependence\n* Current elevated suicidality\n* Severe acute distress\n* No experience of completed rape after age 14'}, 'identificationModule': {'nctId': 'NCT02777294', 'briefTitle': 'Evaluation of Web-Based CBT for Rape Victims', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Evaluation of Web-Based CBT for Rape Victims', 'orgStudyIdInfo': {'id': '1R34MH085118-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R34MH085118-01A2', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online intervention', 'description': 'Therapist-facilitated, cognitive behavioral therapy', 'interventionNames': ['Behavioral: Online intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psycho-educational website', 'description': 'Self-help, psycho-educational website', 'interventionNames': ['Behavioral: Psycho-educational website']}], 'interventions': [{'name': 'Online intervention', 'type': 'BEHAVIORAL', 'description': 'Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD', 'armGroupLabels': ['Online intervention']}, {'name': 'Psycho-educational website', 'type': 'BEHAVIORAL', 'description': 'Psycho-educational self-help website about rape-related PTSD', 'armGroupLabels': ['Psycho-educational website']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}, {'name': 'University of Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Heather Littleton', 'investigatorAffiliation': 'East Carolina University'}}}}