Intervention Study for Individuals With Compulsive Sexual Behavior

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Compulsive Sexual Behavior

Intervention / Treatment
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* Behavioral: STPGP and RPGT
* Drug: TAU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: - individuals who met criteria for: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STPGP and RPGT<br>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<br> <br> |
| Active Comparator: TAU<br>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<br> <br> |
| Experimental: STPGP and RPGT + TAU<br>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<br> <br> Drug: TAU<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Compulsivity Scale (SCS) | Changes in the total score of SCS | Baseline, 25th and 34th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life (WHOQOL-bref) | Changes in the WHOQOL-bref scores. | Baseline and 25th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compulsive sexual behavior, Intervention, Short term psychodynamic group psychotherapy, Sexual addiction, Hypersexual behavior