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Enrolling by invitation NCT04634175

Yoga Intervention for Compulsive Sexual Behavior Disorder

No phase Interventional Compulsive Sexual Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yoga intervention, Sham intervention.
Who it may be relevant to
Registry conditions: Compulsive Sexual Behavior. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

Yoga intervention practice as a complementary and integrative treatment for compulsive sexual behavior disorder (CSBD), 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, yoga intervention practice and Shan intervention practice, 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 yoga intervention practice in decreasing the symptoms (sexual compulsiveness) of the CSBD.

The secondary objectives of the study are to investigate the effectiveness of the yoga intervention practice in reducing the severity of impulsivity, hypersexuality, anxiety, depression, improving the level of quality of life, and increasing adherence to total treatment.

Interventions

  • Behavioral Yoga intervention
    The yoga intervention is composed of kundalini yoga techniques.
  • Behavioral Sham intervention
    The sham intervention is composed of stretching and muscle flexion techniques.

Primary outcome measures

  • Sexual Compulsivity Scale (SCS) [Time frame: Baseline, 4th week, 8th week and 12th week]
Secondary outcome measures (5)
  • Barrat Impulsivity Scale (BIS 11) [Time frame: Baseline, 4th week, 8th week and 12th week]
  • Hypersexual Disorder Screening Inventory (HDSI) [Time frame: Baseline, 4th week, 8th week and 12th week]
  • Beck Anxiety Inventory (BAI) [Time frame: Baseline, 4th week, 8th week and 12th week]
  • Beck Depression Inventory (BDI) [Time frame: Baseline, 4th week, 8th week and 12th week]
  • World Health Organization Quality of Life (WHOQOL-bref) [Time frame: Baseline and 12th week]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University — São Paulo

Identifiers

NCT: NCT04634175 · 30117919.5.0000.0068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗