Intervention Study for Individuals With Compulsive Sexual Behavior

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300051
• Other study ID #: CSB-2
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: December 8, 2015
• Start date: February 2011
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Sexual Behavior

Intervention

Behavioral:
• STPGP and RPGT

Drug:
• TAU

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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

Outcome

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