Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT00067704
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2003-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emotional Disclosure in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-09', 'studyFirstSubmitDate': '2003-08-25', 'studyFirstSubmitQcDate': '2003-08-26', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in psychological distress', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Increase in CD4 T-lymphocytes', 'timeFrame': '1 year'}, {'measure': 'Decrease in the number of HIV symptoms', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Complementary Therapies'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. The goal of the current study is to test the efficacy of emotional disclosure through writing in patients with HIV infection. We will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). \\[Note that HIV RNA viral load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 18-65 years of age inclusive\n* At least 8 years of formal education\n* Literate\n* Fluent in English\n\nAll of the following three must apply:\n\n* No active Category C HIV AIDS-defining symptoms\n* CD4 T-lymphocyte count between 150-499\n* Viral load \\>1000\n\nExclusion Criteria\n\n* Less than 8 years formal education\n* Illiterate or non-English speaking\n* Active systemic diseases that would interfere with participation\n* Current alcohol or substance dependence\n* Planned change in HIV medication in the next 6 months, or recent change in past 2 months\n* Introduction of antidepressant medication within 30 days of study start\n* Current psychological counseling, cognitive behavior therapy, support group or other psychological therapy, or plans to start any of the above\n* Diagnosis of PTSD or major depression\n* Unable to attend at least 4 treatment sessions'}, 'identificationModule': {'nctId': 'NCT00067704', 'briefTitle': 'Emotional Disclosure in HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Efficacy of an Emotional Disclosure Intervention in HIV', 'orgStudyIdInfo': {'id': '20020511'}, 'secondaryIdInfos': [{'id': 'R01AT002035', 'link': 'https://reporter.nih.gov/quickSearch/R01AT002035', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trauma writing', 'description': 'Four sessions of writing about traumatic experiences.', 'interventionNames': ['Behavioral: Trauma writing']}, {'type': 'SHAM_COMPARATOR', 'label': 'Writing about daily events', 'description': 'Four sessions of writing about their daily experiences.', 'interventionNames': ['Behavioral: Writing about daily events']}], 'interventions': [{'name': 'Trauma writing', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Trauma writing']}, {'name': 'Writing about daily events', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Writing about daily events']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33124-2070', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Dept. of Psychology & Behavioral Medicine', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Gail Ironson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami Dept. of Psychology & Behavioral Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gail Ironson', 'investigatorAffiliation': 'University of Miami'}}}}