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Intervention Study for Individuals With Compulsive Sexual Behavior

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ClinicalTrials.gov Identifier: NCT02300051
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Marco de Tubino Scanavino, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Compulsive Sexual Behavior Behavioral: STPGP and RPGT Drug: TAU Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : February 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: 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)
Behavioral: STPGP and RPGT
Active Comparator: 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).
Drug: TAU
Experimental: 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).
Behavioral: STPGP and RPGT
Drug: TAU



Primary Outcome Measures :
  1. Sexual Compulsivity Scale (SCS) [ Time Frame: Baseline, 25th and 34th week ]
    Changes in the total score of SCS


Secondary Outcome Measures :
  1. World Health Organization Quality of Life (WHOQOL-bref) [ Time Frame: Baseline and 25th week ]
    Changes in the WHOQOL-bref scores.


Other Outcome Measures:
  1. Beck Depression Inventory (BDI) [ Time Frame: Baseline and 25th week ]
    Changes in BDI scores

  2. Proportion of use of condom when engaging in anal and vaginal sexual intercourse, number of casual partners [ Time Frame: Baseline, 25th, and 34th week ]
    Changes in proportions of use of condom when engaging in anal and vaginal sexual intercourse, and number of casual partners reported

  3. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline and 25th week ]
    Changes in BAI scores

  4. Barratt Impulsivity Scale (BIS) 11 [ Time Frame: Baseline, 25th, and 34th week ]
    Changes in BIS 11 scores

  5. Adult Attachment Scale (AAS) [ Time Frame: Baseline, and 25th week ]
    Changes in AAS scores

  6. Knowledge and Perceptions regarding HIV transmission [ Time Frame: Baseline, 25th week, and 34th week. ]
    Changes in proportion of knowledge and perceptions on HIV transmission.

  7. Wisconsin Card Sorting Test (WCST) [ Time Frame: Baseline, and 25th week ]
    Changes in scores of the neurocognitive task.

  8. Continuous Performance Test (CPT) [ Time Frame: Baseline, and 25th week ]
    Changes in scores of the neurocognitive task.

  9. Medication adverse effect record [ Time Frame: 25th week ]
    Investigation of medical records on adverse effect



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300051


Locations
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Brazil
Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]
São Paulo, Brazil, 05403010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Marco Scanavino, PhD USP

Publications:

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Responsible Party: Marco de Tubino Scanavino, assistant physician, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02300051     History of Changes
Other Study ID Numbers: CSB-2
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Marco de Tubino Scanavino, University of Sao Paulo General Hospital:
Compulsive sexual behavior
Intervention
Short term psychodynamic group psychotherapy
Sexual addiction
Hypersexual behavior

Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs