An interventional study of STPGP and RPGT and TAU in Compulsive Sexual Behavior, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-09.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
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.
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.
University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria:
Exclusion Criteria: - individuals who met criteria for:
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
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
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
Sexual Compulsivity Scale (SCS)
Changes in the total score of SCS
Time frame: Baseline, 25th and 34th week
World Health Organization Quality of Life (WHOQOL-bref)
Changes in the WHOQOL-bref scores.
Time frame: Baseline and 25th week
Beck Depression Inventory (BDI)
Changes in BDI scores
Time frame: Baseline and 25th week
Proportion of use of condom when engaging in anal and vaginal sexual intercourse, number of casual partners
Changes in proportions of use of condom when engaging in anal and vaginal sexual intercourse, and number of casual partners reported
Time frame: Baseline, 25th, and 34th week
Beck Anxiety Inventory (BAI)
Changes in BAI scores
Time frame: Baseline and 25th week
Barratt Impulsivity Scale (BIS) 11
Changes in BIS 11 scores
Time frame: Baseline, 25th, and 34th week
Adult Attachment Scale (AAS)
Changes in AAS scores
Time frame: Baseline, and 25th week
Knowledge and Perceptions regarding HIV transmission
Changes in proportion of knowledge and perceptions on HIV transmission.
Time frame: Baseline, 25th week, and 34th week.
Wisconsin Card Sorting Test (WCST)
Changes in scores of the neurocognitive task.
Time frame: Baseline, and 25th week
Continuous Performance Test (CPT)
Changes in scores of the neurocognitive task.
Time frame: Baseline, and 25th week
Medication adverse effect record
Investigation of medical records on adverse effect
Time frame: 25th week
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Compulsive Sexual Behavior Disorder
University of Sao Paulo General Hospital