Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02300051
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Study for Individuals With Compulsive Sexual Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096583', 'term': 'Compulsive Sexual Behavior Disorder'}], 'ancestors': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019968', 'term': 'Sexual and Gender Disorders'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-11-20', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'Baseline and 25th week', 'description': 'Changes in BDI scores'}, {'measure': 'Proportion of use of condom when engaging in anal and vaginal sexual intercourse, number of casual partners', 'timeFrame': 'Baseline, 25th, and 34th week', 'description': 'Changes in proportions of use of condom when engaging in anal and vaginal sexual intercourse, and number of casual partners reported'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Baseline and 25th week', 'description': 'Changes in BAI scores'}, {'measure': 'Barratt Impulsivity Scale (BIS) 11', 'timeFrame': 'Baseline, 25th, and 34th week', 'description': 'Changes in BIS 11 scores'}, {'measure': 'Adult Attachment Scale (AAS)', 'timeFrame': 'Baseline, and 25th week', 'description': 'Changes in AAS scores'}, {'measure': 'Knowledge and Perceptions regarding HIV transmission', 'timeFrame': 'Baseline, 25th week, and 34th week.', 'description': 'Changes in proportion of knowledge and perceptions on HIV transmission.'}, {'measure': 'Wisconsin Card Sorting Test (WCST)', 'timeFrame': 'Baseline, and 25th week', 'description': 'Changes in scores of the neurocognitive task.'}, {'measure': 'Continuous Performance Test (CPT)', 'timeFrame': 'Baseline, and 25th week', 'description': 'Changes in scores of the neurocognitive task.'}, {'measure': 'Medication adverse effect record', 'timeFrame': '25th week', 'description': 'Investigation of medical records on adverse effect'}], 'primaryOutcomes': [{'measure': 'Sexual Compulsivity Scale (SCS)', 'timeFrame': 'Baseline, 25th and 34th week', 'description': 'Changes in the total score of SCS'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Quality of Life (WHOQOL-bref)', 'timeFrame': 'Baseline and 25th week', 'description': 'Changes in the WHOQOL-bref scores.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Compulsive sexual behavior', 'Intervention', 'Short term psychodynamic group psychotherapy', 'Sexual addiction', 'Hypersexual behavior'], 'conditions': ['Compulsive Sexual Behavior']}, 'referencesModule': {'references': [{'pmid': '25348356', 'type': 'BACKGROUND', 'citation': 'Scanavino Mde T, Ventuneac A, Rendina HJ, Abdo CH, Tavares H, Amaral ML, Messina B, Reis SC, Martins JP, Gordon MC, Vieira JC, Parsons JT. Sexual Compulsivity Scale, Compulsive Sexual Behavior Inventory, and Hypersexual Disorder Screening Inventory: Translation, Adaptation, and Validation for Use in Brazil. Arch Sex Behav. 2016 Jan;45(1):207-17. doi: 10.1007/s10508-014-0356-5. Epub 2014 Oct 28.'}, {'pmid': '23415890', 'type': 'BACKGROUND', 'citation': 'Scanavino Mde T, Ventuneac A, Abdo CH, Tavares H, do Amaral ML, Messina B, dos Reis SC, Martins JP, Parsons JT. Compulsive sexual behavior and psychopathology among treatment-seeking men in Sao Paulo, Brazil. Psychiatry Res. 2013 Oct 30;209(3):518-24. doi: 10.1016/j.psychres.2013.01.021. Epub 2013 Feb 15.'}, {'pmid': '22729419', 'type': 'BACKGROUND', 'citation': 'Amaral ML, Scanavino Mde T. Severe compulsive sexual behaviors: a report on two cases under treatment. Braz J Psychiatry. 2012 Jun;34(2):213-4. doi: 10.1590/s1516-44462012000200015. No abstract available. English, Portuguese.'}, {'pmid': '19578698', 'type': 'BACKGROUND', 'citation': 'Scanavino Mde T, Torres RR, Abdo CH, Rego MA, Fernandez FM. Sexual compulsion and HIV transmission: a case report. Braz J Psychiatry. 2009 Jun;31(2):189-90. doi: 10.1590/s1516-44462009000200022. No abstract available.'}, {'pmid': '19937105', 'type': 'BACKGROUND', 'citation': 'Kafka MP. Hypersexual disorder: a proposed diagnosis for DSM-V. Arch Sex Behav. 2010 Apr;39(2):377-400. doi: 10.1007/s10508-009-9574-7.'}, {'pmid': '17194276', 'type': 'BACKGROUND', 'citation': "Wainberg ML, Muench F, Morgenstern J, Hollander E, Irwin TW, Parsons JT, Allen A, O'Leary A. A double-blind study of citalopram versus placebo in the treatment of compulsive sexual behaviors in gay and bisexual men. J Clin Psychiatry. 2006 Dec;67(12):1968-73. doi: 10.4088/jcp.v67n1218."}, {'pmid': '20358460', 'type': 'BACKGROUND', 'citation': 'Kaplan MS, Krueger RB. Diagnosis, assessment, and treatment of hypersexuality. J Sex Res. 2010 Mar;47(2):181-98. doi: 10.1080/00224491003592863.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is compare three interventions (short-term psychodynamic psychotherapeutic group and relapse prevention group therapy vs. treatment as usual, namely, psychiatric follow up including prescription of medication vs. both interventions combined) to individuals presenting compulsive sexual behavior.', 'detailedDescription': "We will compare three groups of patients under the three interventions, namely, (1) Short-Term Psychodynamic Group Psychotherapy (STPGP) followed by Relapse Prevention Group Therapy (RPGT) (n = 48) vs. (2) Treatment as Usual (TAU) (n = 42) vs. (3) both previous interventions combined (n = 45).\n\nThe STPGP is a 16 weekly session's group psychotherapy. Each session lasts 90 minutes. Each group will consist of around 10 participants. All the groups of STPGP will be conducted by the same psychotherapist.\n\nThe RPGT is an eight weekly therapy group. The sessions are structured and will last 90 minutes.\n\nThe medication used by those who are under TAU will be introduced through psychiatric care. Initially three visits will occur at intervals of 30 days and the followings will occur with an interval of 60 days. The medication protocol includes serotonin reuptake inhibitors (fluoxetine, paroxetine, sertraline) or mood stabilizers (topiramate, divalproex sodium, oxcarbazepine) or both type of medications combined.\n\nAll patients will be assessed on the outcomes and independent variables in the baseline (time 0); in the 25th week (time 1); and 34th week (time 2) of treatment."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. meeting the criteria for "excessive sexual drive" (ICD-10 F52.7) which corresponds to complain of an excessive sexual drive that often leads to out of control sexual behaviors AND meeting the criteria for "sex addiction" by Goodman (2001), which is characterized as a maladaptive pattern of sexual behavior leading to clinically impairment or distress as manifested in the same 12-month period by three or more of the following: tolerance (process of engaging in increasingly sexual behavior, in terms of intensity and frequency to obtain the same satisfaction than before); withdrawal (experience of abstinence, characterized by the presence of physical and/or psychological symptoms, when the behavior is diminished or discontinued); frequent sexual behavior; unsuccessful efforts to control it; many time spent in preparation for it; social or occupational activities are diminished because of it; it goes on despite negative outcomes;\n2. being literate in Portuguese;\n3. cognitive ability to answer self-responsive measures.\n\nExclusion Criteria: - individuals who met criteria for:\n\n1. sexual preference disorders (ICD-10 F65);\n2. manic or hypomanic state of bipolar disorder (ICD-10 F30.0, F31.0, 31.1, and 31.2);\n3. schizophrenia, schizotypal, and delusional disorders (ICD-10 F20 - F29);\n4. other mental disorders due to brain dysfunction, injury or physical disease (ICD-10 F06);\n5. gender identity disorder (ICD-10 F64).'}, 'identificationModule': {'nctId': 'NCT02300051', 'briefTitle': 'Intervention Study for Individuals With Compulsive Sexual Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Sexual Risk Behavior, Clinical and Psychopathological Aspects of Individuals With Compulsive Sexual Behavior of the Institute of Psychiatry of the General Hospital of the University of São Paulo Medical School, an Intervention Study.', 'orgStudyIdInfo': {'id': 'CSB-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STPGP and RPGT', 'description': '16 weekly sessions of 90 minutes of Short-Term Psychodynamic Group Psychotherapy (STPGP) followed by 8 weekly sessions of 90 minutes of Relapse Prevention Group Therapy (RPGT)', 'interventionNames': ['Behavioral: STPGP and RPGT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU', 'description': 'Treatment as usual (TAU) will be introduced through psychiatric follow up, in which the three first visits will occur at intervals of 30 days and the followings will occur with an interval of 60 days. The medication protocol includes serotonin reuptake inhibitors (fluoxetine 20 - 80 mg/day, paroxetine 20 - 60 mg/day, sertraline 50 - 200 mg/day) or mood stabilizers (topiramate 25 - 200 mg/day, divalproex sodium (500 - 1500 mg/day, oxcarbazepine (300 - 1200 mg/day, and lamotrigine 50 - 200 mg/day).', 'interventionNames': ['Drug: TAU']}, {'type': 'EXPERIMENTAL', 'label': 'STPGP and RPGT + TAU', 'description': 'Participants undergo both interventions: 1) 16 weekly sessions of 90 minutes of Short-Term Psychodynamic Group Psychotherapy (STPGP) followed by 8 weekly sessions of 90 minutes of Relapse Prevention Group Therapy (RPGT); 2)Treatment as usual (TAU) will be introduced through psychiatric follow up, in which the three first visits will occur at intervals of 30 days and the followings will occur with an interval of 60 days. The medication protocol includes serotonin reuptake inhibitors (fluoxetine 20 - 80 mg/day, paroxetine 20 - 60 mg/day, sertraline 50 - 200 mg/day) or mood stabilizers (topiramate 25 - 200 mg/day, divalproex sodium (500 - 1500 mg/day, oxcarbazepine (300 - 1200 mg/day, and lamotrigine 50 - 200 mg/day).', 'interventionNames': ['Behavioral: STPGP and RPGT', 'Drug: TAU']}], 'interventions': [{'name': 'STPGP and RPGT', 'type': 'BEHAVIORAL', 'armGroupLabels': ['STPGP and RPGT', 'STPGP and RPGT + TAU']}, {'name': 'TAU', 'type': 'DRUG', 'armGroupLabels': ['STPGP and RPGT + TAU', 'TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Marco Scanavino, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant physician', 'investigatorFullName': 'Marco de Tubino Scanavino', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}