Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01803802
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2013-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Early Abuse on Adult Intimate Relationships
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual Dysfunction Interview', 'timeFrame': '6 months', 'description': 'Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': '6 months', 'description': 'As measured by clinical interview and validated questionnaires'}, {'measure': 'Post-Traumatic Stress', 'timeFrame': '6 months', 'description': 'As measured by clinical interview and validated questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['childhood sexual abuse', 'depression', 'PTSD', 'sexual function', 'women'], 'conditions': ['Hypoactive Sexual Desire Disorder', 'Female Sexual Arousal Disorder', 'Female Orgasmic Disorder', 'Major Depressive Disorder', 'Post-traumatic Stress Disorder']}, 'referencesModule': {'references': [{'pmid': '23875721', 'type': 'DERIVED', 'citation': 'Meston CM, Lorenz TA, Stephenson KR. Effects of expressive writing on sexual dysfunction, depression, and PTSD in women with a history of childhood sexual abuse: results from a randomized clinical trial. J Sex Med. 2013 Sep;10(9):2177-89. doi: 10.1111/jsm.12247. Epub 2013 Jul 22.'}], 'seeAlsoLinks': [{'url': 'http://mestonlab.com', 'label': 'Link to laboratory website'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to help us better understand the factors that affect the sexual lives of women who have been sexually mistreated during childhood. With this study we hope to learn about factors that may be promising targets for future treatments of sexual problems related to past sexual experiences. The investigators hypothesize that women who have experienced early sexual abuse are more likely to have sexual problems in adulthood than women who were not abuse in childhood.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least one involuntary sexual experience, defined as "unwanted oral, anal, or vaginal intercourse, penetration of the vagina or anus using objects or digits, or genital touching or fondling," before age 16 and no less than 2 years prior to enrollment.\n* currently sexually active or cohabiting in a potentially sexual relationship.\n* current sexual dysfunction, distress, or low sexual satisfaction\n\nExclusion Criteria:\n\n* traumatic event in the previous three months\n* sexual abuse in the past two years\n* diagnosis of a psychotic disorder in the previous six months\n* significant suicidal or homicidal intent\n* currently receiving psychotherapy for sexual or abuse-related concerns\n* use of illicit drugs\n* in a currently abusive relationship'}, 'identificationModule': {'nctId': 'NCT01803802', 'briefTitle': 'Effects of Early Abuse on Adult Intimate Relationships', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Effects of Early Abuse on Adult Intimate Relationships', 'orgStudyIdInfo': {'id': '1R01HD051676', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD051676', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HD051676', 'link': 'https://reporter.nih.gov/quickSearch/R01HD051676', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Time management', 'description': 'Writing prompts oriented towards objective recounting of previous day', 'interventionNames': ['Behavioral: Expressive writing']}, {'type': 'EXPERIMENTAL', 'label': 'Sexual schema writing', 'description': 'Expressive writing prompts oriented towards beliefs about sexuality', 'interventionNames': ['Behavioral: Expressive writing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trauma writing', 'description': 'Expressive writing prompts oriented towards processing traumatic experiences', 'interventionNames': ['Behavioral: Expressive writing']}], 'interventions': [{'name': 'Expressive writing', 'type': 'BEHAVIORAL', 'description': 'Five sessions of 30 minutes of expressive writing', 'armGroupLabels': ['Sexual schema writing', 'Time management', 'Trauma writing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Coordinator', 'investigatorFullName': 'Tierney Kyle Ahrold Lorenz', 'investigatorAffiliation': 'University of Texas at Austin'}}}}