Intervention Study for Individuals With Compulsive Sexual Behavior

NCT02300051 | Completed DMC

• 1 other identifier: CSB-2
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Compulsive Sexual Behavior

Keywords

Compulsive sexual behavior; Intervention; Short term psychodynamic group psychotherapy; Sexual addiction; Hypersexual behavior

Outcome Measures

Primary Outcomes (1)

• Sexual Compulsivity Scale (SCS)

  Changes in the total score of SCS

  Baseline, 25th and 34th week

Secondary Outcomes (1)

• World Health Organization Quality of Life (WHOQOL-bref)

  Baseline and 25th week

Other Outcomes (9)

• Beck Depression Inventory (BDI)

  Baseline and 25th week

• Proportion of use of condom when engaging in anal and vaginal sexual intercourse, number of casual partners

  Baseline, 25th, and 34th week

• Beck Anxiety Inventory (BAI)

  Baseline and 25th week

Study Arms (3)

STPGP and RPGT

EXPERIMENTAL

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)

Behavioral: STPGP and RPGT

TAU

ACTIVE COMPARATOR

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).

Drug: TAU

STPGP and RPGT + TAU

EXPERIMENTAL

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).

Behavioral: STPGP and RPGT; Drug: TAU

Interventions

STPGP and RPGT BEHAVIORAL

STPGP and RPGT; STPGP and RPGT + TAU

TAU DRUG

STPGP and RPGT + TAU; TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• being literate in Portuguese;
• cognitive ability to answer self-responsive measures.

You may not qualify if:

• sexual preference disorders (ICD-10 F65);
• manic or hypomanic state of bipolar disorder (ICD-10 F30.0, F31.0, 31.1, and 31.2);
• schizophrenia, schizotypal, and delusional disorders (ICD-10 F20 - F29);
• other mental disorders due to brain dysfunction, injury or physical disease (ICD-10 F06);
• gender identity disorder (ICD-10 F64).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (7)

• 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: 25348356 BACKGROUND

• 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: 23415890 BACKGROUND

• 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: 22729419 BACKGROUND

• 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: 19578698 BACKGROUND

• 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: 19937105 BACKGROUND

• 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: 17194276 BACKGROUND

• Kaplan MS, Krueger RB. Diagnosis, assessment, and treatment of hypersexuality. J Sex Res. 2010 Mar;47(2):181-98. doi: 10.1080/00224491003592863.

  PMID: 20358460 BACKGROUND

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Sexual and Gender Disorders; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Marco Scanavino, PhD

  USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant physician

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 24, 2014
• Study Start: February 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

BR (1)