Compulsive Sexual BehaviorNCT02300051
Intervention Study for Individuals With Compulsive Sexual Behavior
A study testing STPGP and RPGT and TAU in people with Compulsive Sexual Behavior, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Compulsive Sexual Behavior
- What is being tested?
- STPGP and RPGT and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]
São Paulo, São Paulo, 05403010
About this study
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.
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.
Read the 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.
- Conditions
- Compulsive Sexual Behavior
- Being tested
- STPGP and RPGT, TAU
- Keywords
- Compulsive sexual behavior, Intervention, Short term psychodynamic group psychotherapy, Sexual addiction, Hypersexual behavior
- Medical subject headings
- Compulsive Sexual Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STPGP and RPGTBehavioural
TAUDrug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: 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). Receives: Behavioral: STPGP and RPGT; Drug: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Compulsivity Scale (SCS)
Changes in the total score of SCS
Measured: Baseline, 25th and 34th week
Secondary outcomes (1)
World Health Organization Quality of Life (WHOQOL-bref)
Changes in the WHOQOL-bref scores.
Measured: Baseline and 25th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startFeb 2011
- Primary completionApr 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Compulsive Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco de Tubino Scanavino, University of Sao Paulo General Hospital
- Investigators
- Marco Scanavino, PhD, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300051
- Sponsor's protocol ID
- CSB-2
- Status last verified
- Dec 2015
- First submitted
- 18 Nov 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25348356Scanavino 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.
PubMed 23415890Amaral 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.
PubMed 22729419Scanavino 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.
PubMed 19578698Kafka 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.
PubMed 19937105Wainberg 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.
PubMed 17194276Kaplan MS, Krueger RB. Diagnosis, assessment, and treatment of hypersexuality. J Sex Res. 2010 Mar;47(2):181-98. doi: 10.1080/00224491003592863.
PubMed 20358460
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02300051
- Acronym / sponsor ID
- CSB-2
- Conditions
- Compulsive Sexual Behavior
- Keywords
- Compulsive sexual behavior, Intervention, Short term psychodynamic group psychotherapy, Sexual addiction, Hypersexual behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STPGP and RPGT | Experimental | Behavioral: STPGP and RPGT16 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) |
| TAU | Active comparator | Drug: TAUTreatment 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). |
| STPGP and RPGT + TAU | Experimental | Behavioral: STPGP and RPGT, Drug: TAUParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STPGP and RPGT | Behavioural | STPGP and RPGT, STPGP and RPGT + TAU |
| TAU | Drug | STPGP and RPGT + TAU, TAU |
Primary outcome
Sexual Compulsivity Scale (SCS)
Time frame: Baseline, 25th and 34th week
Changes in the total score of SCS
1 secondary outcome
World Health Organization Quality of Life (WHOQOL-bref)
Time frame: Baseline and 25th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 25348356Scanavino 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.
- Background: PubMed 23415890Scanavino 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.
- Background: PubMed 22729419Amaral 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.
- Background: PubMed 19578698Scanavino 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.
- Background: PubMed 19937105Kafka 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.
- Background: PubMed 17194276Wainberg 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.
- Background: PubMed 20358460Kaplan MS, Krueger RB. Diagnosis, assessment, and treatment of hypersexuality. J Sex Res. 2010 Mar;47(2):181-98. doi: 10.1080/00224491003592863.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Scanavino, PhD principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STPGP and RPGT and TAU in people with Compulsive Sexual Behavior, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Compulsivity Scale (SCS) (time frame: Baseline, 25th and 34th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02300051, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.