Mind-body Intervention for Compulsive Sexual Behavior Disorder

Compulsive Sexual Behavior Clinical Trial

— CSBD  

Official title:

Mind-Body Intervention Practice as a Complementary and Integrative Treatment for Compulsive Sexual Behavior Disorder: Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04634175
• Other study ID #: 30117919.5.0000.0068
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: September 3, 2025

Study information

• Verified date: February 2024
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: September 3, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Compulsive Sexual Behavior
• Mental Disorders

Intervention

Behavioral:
• Mind-body intervention
The mind-body intervention is composed of kundalini yoga techniques.
• Sham intervention
The sham intervention is composed of stretching and muscle flexion techniques.

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Compulsivity Scale (SCS)	Changes in the total score of Sexual Compulsivity Scale, the scores vary between 10 and 40, with the highest ones indicating greater sexual compulsiveness.	Baseline, 4th week, 8th week and 12th week
Secondary	Barrat Impulsivity Scale (BIS 11)	Changes in the total score of Barrat Impulsivity Scale, the scores vary between 1 and 30, with the highest ones indicating greater impulsivity.	Baseline, 4th week, 8th week and 12th week
Secondary	Hypersexual Disorder Screening Inventory (HDSI)	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.	Baseline, 4th week, 8th week and 12th week
Secondary	Beck Anxiety Inventory (BAI)	Changes in the total score of Beck Anxiety Inventory, the scores vary between 0 and 63, with the highest ones indicating greater anxiety.	Baseline, 4th week, 8th week and 12th week
Secondary	Beck Depression Inventory (BDI)	Changes in the total score of Beck Depression Inventory, the scores vary between 0 and 63, with the highest ones meaning greater depression.	Baseline, 4th week, 8th week and 12th week
Secondary	World Health Organization Quality of Life (WHOQOL-bref)	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.	Baseline and 12th week
Secondary	Sexual Inhibition Scale (SIS)	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.	Baseline and 12th week
Secondary	Sexual Excitation Scale (SES)	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.	Baseline and 12th week
Secondary	International Index of Erectile Function (IIFE)	Changes in IIFE score, the scores are defined as absent, mild, moderate and severe, with the highest ones meaning greater dysfunction.	Baseline and 12th week