Clinical trial NCT04634175: Mind-body Intervention for Compulsive Sexual Behavior Disorder
Official title: Mind-Body Intervention Practice as a Complementary and Integrative Treatment for Compulsive Sexual Behavior Disorder: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Compulsive Sexual Behavior
Keywords: Sexual Compulsion
Hypersexuality
Sex addiction
Disorder
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-test-post-test.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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);
2. Male;
3. Being Brazilian;
4. Literate in Brazilian Portuguese;
5. Have a satisfactory cognitive level to understand and respond to self-responsive inventories;
6. Have availability to participate in a daily mind-body Intervention program for 12 weeks.

Exclusion Criteria:

1. Individuals who meeting the criteria for Substance-Related Disorder and Addictive Disorders (DSM-5, 483);
2. Individuals who meeting the criteria for Paraphilic Disorders (DSM-5, 685);
3. Individuals who meeting the criteria for Gender Dysphoria (DSM-5, 451);
4. Individuals who meeting the criteria for Spectrum of Schizophrenia and other Psychotic Disorders (DSM-5, 87);
5. Individuals who meeting the criteria for Hypomanic or Manic Episode of Mood Disorder (DSM-5, 123);
6. Individuals who meeting the criteria for Neurocognitive Disorders (DSM-5, 591);
7. Individuals who meeting the criteria for Other Mental Disorders (DSM-5, 707);
8. Individuals who have already have practiced kundalini yoga;
9. Individuals who use psychiatric medication and cannot maintain the stability and regularity of the dosage three months before and during the intervention program;
10. Individuals who have attended psychotherapy in the last six months in weekly sessions and with at least 75% attendance;
11. 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.

Primary outcomes:
measure: Sexual Compulsivity Scale (SCS)
timeFrame: Baseline, 4th week, 8th week and 12th week
Secondary outcomes:
measure: Barrat Impulsivity Scale (BIS 11)
timeFrame: Baseline, 4th week, 8th week and 12th week
measure: Hypersexual Disorder Screening Inventory (HDSI)
timeFrame: Baseline, 4th week, 8th week and 12th week
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline, 4th week, 8th week and 12th week
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline, 4th week, 8th week and 12th week
measure: World Health Organization Quality of Life (WHOQOL-bref)
timeFrame: Baseline and 12th week
measure: Sexual Inhibition Scale (SIS)
timeFrame: Baseline and 12th week
measure: Sexual Excitation Scale (SES)
timeFrame: Baseline and 12th week
measure: International Index of Erectile Function (IIFE)
timeFrame: Baseline and 12th week
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Marco Scanavino, PHD
role: PRINCIPAL_INVESTIGATOR
References: