Intervention Study for Individuals With Compulsive Sexual Behavior
Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Compulsive Sexual Behavior
Intervention: STPGP and RPGT (Behavioral); TAU (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Sao Paulo General Hospital Official(s) and/or principal investigator(s): Marco Scanavino, PhD, Principal Investigator, Affiliation: USP
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sexual Compulsivity Scale (SCS)
Secondary outcome: World Health Organization Quality of Life (WHOQOL-bref)
Detailed description:
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).
The 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.
The RPGT is an eight weekly therapy group. The sessions are structured and will last 90
minutes.
The 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.
All 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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).
Locations and Contacts
Instituto de Psiquiatria do Hospital das ClÃnicas da Universidade de São Paulo[University of Sao Paulo General Hospital], São Paulo 05403010, Brazil
Additional Information
Related publications: Scanavino MT, 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. 2014 Oct 28. [Epub ahead of print] 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. 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. 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. 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. 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. Kaplan MS, Krueger RB. Diagnosis, assessment, and treatment of hypersexuality. J Sex Res. 2010 Mar;47(2):181-98. doi: 10.1080/00224491003592863. Review.
Starting date: February 2011
Last updated: November 20, 2014
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