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Completed

NCT Number: NCT02300051

Intervention Study for Individuals With Compulsive Sexual Behavior

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

STPGP and RPGT

Behavioral

TAU

Drug

Primary outcomes

  1. Sexual Compulsivity Scale (SCS)

    Time frame: Baseline, 25th and 34th week

    Changes in the total score of SCS

Secondary outcomes

  1. World Health Organization Quality of Life (WHOQOL-bref)

    Time frame: Baseline and 25th week

    Changes in the WHOQOL-bref scores.

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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