Compulsive Sexual Behavior Clinical Trial
Official title:
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.
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.
Status | Completed |
Enrollment | 135 |
Est. completion date | July 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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; 2. being literate in Portuguese; 3. cognitive ability to answer self-responsive measures. Exclusion Criteria: - individuals who met criteria for: 1. sexual preference disorders (ICD-10 F65); 2. manic or hypomanic state of bipolar disorder (ICD-10 F30.0, F31.0, 31.1, and 31.2); 3. schizophrenia, schizotypal, and delusional disorders (ICD-10 F20 - F29); 4. other mental disorders due to brain dysfunction, injury or physical disease (ICD-10 F06); 5. gender identity disorder (ICD-10 F64). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital] | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Amaral ML, Scanavino Mde T. Severe compulsive sexual behaviors: a report on two cases under treatment. Rev Bras Psiquiatr. 2012 Jun;34(2):213-4. English, Portuguese. — View 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. Review. — View Citation
Kaplan MS, Krueger RB. Diagnosis, assessment, and treatment of hypersexuality. J Sex Res. 2010 Mar;47(2):181-98. doi: 10.1080/00224491003592863. Review. — View Citation
Scanavino Mde T, Torres RR, Abdo CH, Rego MA, Fernandez FM. Sexual compulsion and HIV transmission: a case report. Rev Bras Psiquiatr. 2009 Jun;31(2):189-90. — View 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 São Paulo, Brazil. Psychiatry Res. 2013 Oct 30;209(3):518-24. doi: 10.1016/j.psychres.2013.01.021. Epub 2013 Feb 15. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Beck Depression Inventory (BDI) | Changes in BDI scores | Baseline and 25th week | No |
Other | Proportion of use of condom when engaging in anal and vaginal sexual intercourse, number of casual partners | Changes in proportions of use of condom when engaging in anal and vaginal sexual intercourse, and number of casual partners reported | Baseline, 25th, and 34th week | No |
Other | Beck Anxiety Inventory (BAI) | Changes in BAI scores | Baseline and 25th week | No |
Other | Barratt Impulsivity Scale (BIS) 11 | Changes in BIS 11 scores | Baseline, 25th, and 34th week | No |
Other | Adult Attachment Scale (AAS) | Changes in AAS scores | Baseline, and 25th week | No |
Other | Knowledge and Perceptions regarding HIV transmission | Changes in proportion of knowledge and perceptions on HIV transmission. | Baseline, 25th week, and 34th week. | No |
Other | Wisconsin Card Sorting Test (WCST) | Changes in scores of the neurocognitive task. | Baseline, and 25th week | No |
Other | Continuous Performance Test (CPT) | Changes in scores of the neurocognitive task. | Baseline, and 25th week | No |
Other | Medication adverse effect record | Investigation of medical records on adverse effect | 25th week | Yes |
Primary | Sexual Compulsivity Scale (SCS) | Changes in the total score of SCS | Baseline, 25th and 34th week | No |
Secondary | World Health Organization Quality of Life (WHOQOL-bref) | Changes in the WHOQOL-bref scores. | Baseline and 25th week | No |
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