Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02300051
Other study ID # CSB-2
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT00467558 - Double-Blind Naltrexone in Compulsive Sexual Behavior Phase 2
Recruiting NCT06408545 - Acceptance and Commitment Therapy for Problematic Chemsex N/A
Not yet recruiting NCT06406296 - Effectiveness of ACT for Problematic Chemsex N/A
Enrolling by invitation NCT04634175 - Mind-body Intervention for Compulsive Sexual Behavior Disorder N/A
Completed NCT05572372 - Effects of an ACT-based Psychological Treatment in Patients With Hypersexuality N/A
Completed NCT03495414 - Neurobiological Underpinnings to Hypersexual Disorder