Yoga Intervention for Compulsive Sexual Behavior Disorder

NCT04634175 | Enrolling By Invitation

• 1 other identifier: 30117919.5.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Yoga intervention as a complementary and integrative treatment for compulsive sexual behavior disorder (CSBD). The hypothesis is that participants with CSBD, after being submitted to the protocol of the yoga intervention group in relation to those submitted to the intervention protocol Shan of the control group, present less severe sexual compulsiveness.

Conditions

Compulsive Sexual Behavior

Keywords

Sexual Compulsion; Hypersexuality; Sex addiction; Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Barrat Impulsivity Scale (BIS 11)

  Baseline, 4th week, 8th week and 12th week

• Hypersexual Disorder Screening Inventory (HDSI)

  Baseline, 4th week, 8th week and 12th week

• Beck Anxiety Inventory (BAI)

  Baseline, 4th week, 8th week and 12th week

• Beck Depression Inventory (BDI)

  Baseline, 4th week, 8th week and 12th week

• World Health Organization Quality of Life (WHOQOL-bref)

  Baseline and 12th week

Study Arms (2)

Yoga group

EXPERIMENTAL

The yoga group will practice yoga intervention.

Behavioral: Yoga intervention

Sham group

ACTIVE COMPARATOR

The sham group will practice muscle stretching intervention.

Behavioral: Sham intervention

Interventions

Yoga intervention BEHAVIORAL

The yoga intervention is composed of kundalini yoga techniques.

Yoga group

Sham intervention BEHAVIORAL

The sham intervention is composed of stretching and muscle flexion techniques.

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder; Disease

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Sexual and Gender Disorders; Sexual Dysfunctions, Psychological; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Scanavino, PHD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Volunteers, health care professionals and researchers will not have access to randomization and will also not know which intervention group they were assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-test-post-test.

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: July 15, 2021
• Primary Completion: February 24, 2025
• Study Completion: September 3, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-07

Locations

BR (1)