MedDataX Logo

Intervention Study for Individuals With Compulsive Sexual Behavior

NCT ID: NCT02300051

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Compulsive Sexual Behavior

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STPGP and RPGT

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)

Group Type EXPERIMENTAL

STPGP and RPGT

Intervention Type BEHAVIORAL

TAU

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).

Group Type ACTIVE_COMPARATOR

TAU

Intervention Type DRUG

STPGP and RPGT + TAU

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).

Group Type EXPERIMENTAL

STPGP and RPGT

Intervention Type BEHAVIORAL

TAU

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STPGP and RPGT

Intervention Type BEHAVIORAL

TAU

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marco de Tubino Scanavino

assistant physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marco Scanavino, PhD

Role: PRINCIPAL_INVESTIGATOR

USP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25348356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23415890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22729419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19578698 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19937105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17194276 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20358460 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSB-2

Identifier Type: -

Identifier Source: org_study_id