Mind-body Intervention for Compulsive Sexual Behavior Disorder
- Conditions
- Compulsive Sexual Behavior
- Interventions
- Behavioral: Mind-body interventionBehavioral: Sham intervention
- Registration Number
- NCT04634175
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
Mind-body intervention as a complementary and integrative treatment for compulsive sexual behavior disorder.
The hypothesis is that participants with CSBD, after being submitted to the protocol of the mind-body intervention group in relation to those submitted to the intervention protocol Shan of the control group, present less severe sexual compulsiveness.
- Detailed Description
Mind-body intervention practice as a complementary and integrative treatment for compulsive sexual behavior disorder, a randomized clinical trial, in a sample of male individuals who spontaneously seek treatment at the Psychiatry Institute of Hospital das Clínicas, University of São Paulo.
The volunteers with CSBD will be randomized by statistical software in two groups, mind-body intervention and Shan intervention, to participate in a twelve-week program of daily practices of the mind-body practices protocol.
The participants will be evaluated by measuring instruments at time 1 (4th week), time 2 (8th week) and time 3 (12th week).
The primary objective of the study is to investigate the effectiveness of mind-body intervention in decreasing the symptoms (sexual compulsiveness) of the CSBD.
The secondary objectives of the study are to investigate the effectiveness of the mind-body intervention in reducing the severity of impulsivity, hypersexuality, anxiety, depression, improving the level of quality of life, increasing adherence to total treatment, regulating sexual inhibition, sexual arousal and decrease the severity of sexual dysfunction.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 60
- They must have a minimum score of 28 on the Sexual Compulsiveness Scale (range 10 - 40) or a minimum score of 20 on the Screening Inventory of Hypersexual Disorder (range 0 - 28) and a minimum score of 14 on the Beck Anxiety Inventory (range of 0 - 63);
- Male;
- Being Brazilian;
- Literate in Brazilian Portuguese;
- Have a satisfactory cognitive level to understand and respond to self-responsive inventories;
- Have availability to participate in a daily mind-body Intervention program for 12 weeks.
- Individuals who meeting the criteria for Substance-Related Disorder and Addictive Disorders (DSM-5, 483);
- Individuals who meeting the criteria for Paraphilic Disorders (DSM-5, 685);
- Individuals who meeting the criteria for Gender Dysphoria (DSM-5, 451);
- Individuals who meeting the criteria for Spectrum of Schizophrenia and other Psychotic Disorders (DSM-5, 87);
- Individuals who meeting the criteria for Hypomanic or Manic Episode of Mood Disorder (DSM-5, 123);
- Individuals who meeting the criteria for Neurocognitive Disorders (DSM-5, 591);
- Individuals who meeting the criteria for Other Mental Disorders (DSM-5, 707);
- Individuals who have already have practiced kundalini yoga;
- Individuals who use psychiatric medication and cannot maintain the stability and regularity of the dosage three months before and during the intervention program;
- Individuals who have attended psychotherapy in the last six months in weekly sessions and with at least 75% attendance;
- Individuals who have significant spinal problems and / or physical limitations that may interfere with yoga practice, for example, overweight, severe lung and / or cardiovascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mind-body group Mind-body intervention The mind-body group will practice mind-body intervention. Sham group Sham intervention The sham group will practice sham intervention.
- Primary Outcome Measures
Name Time Method Sexual Compulsivity Scale (SCS) Baseline, 4th week, 8th week and 12th week Changes in the total score of Sexual Compulsivity Scale, the scores vary between 10 and 40, with the highest ones indicating greater sexual compulsiveness.
- Secondary Outcome Measures
Name Time Method Sexual Excitation Scale (SES) Baseline and 12th week Changes in the total score of Sexual Excitation Scale, the scores are defined as strongly agree, agree, disagree and strongly disagree, the highest scores mean greater sexual excitation.
Barrat Impulsivity Scale (BIS 11) Baseline, 4th week, 8th week and 12th week Changes in the total score of Barrat Impulsivity Scale, the scores vary between 1 and 30, with the highest ones indicating greater impulsivity.
Hypersexual Disorder Screening Inventory (HDSI) Baseline, 4th week, 8th week and 12th week Changes in the total score of Hypersexual Disorder Screening Inventory score, the scores vary between 0 and 28, with the highest ones indicating greater hypersexuality.
World Health Organization Quality of Life (WHOQOL-bref) Baseline and 12th week Changes in the total score of World Health Organization Quality of Life-bref, the scores vary from 26 to 130, with the highest ones meaning greater quality of life.
International Index of Erectile Function (IIFE) Baseline and 12th week Changes in IIFE score, the scores are defined as absent, mild, moderate and severe, with the highest ones meaning greater dysfunction.
Beck Anxiety Inventory (BAI) Baseline, 4th week, 8th week and 12th week Changes in the total score of Beck Anxiety Inventory, the scores vary between 0 and 63, with the highest ones indicating greater anxiety.
Beck Depression Inventory (BDI) Baseline, 4th week, 8th week and 12th week Changes in the total score of Beck Depression Inventory, the scores vary between 0 and 63, with the highest ones meaning greater depression.
Sexual Inhibition Scale (SIS) Baseline and 12th week Changes in the total score of Sexual Inhibition Scale, the scores are defined as strongly agree, agree, disagree and strongly disagree, the highest scores mean greater sexual inhibition.
Trial Locations
- Locations (1)
Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]
🇧🇷São Paulo, SP, Brazil