- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634175
Yoga Intervention for Compulsive Sexual Behavior Disorder (CSBD)
Yoga Intervention Practice as a Complementary and Integrative Treatment for Compulsive Sexual Behavior Disorder: Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
São Paulo, São Paulo, Brazil, 05403-010
- Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga group
The yoga group will practice yoga intervention.
|
The yoga intervention is composed of kundalini yoga techniques.
|
|
Active Comparator: Sham group
The sham group will practice muscle stretching intervention.
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The sham intervention is composed of stretching and muscle flexion techniques.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Compulsivity Scale (SCS)
Time Frame: 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.
|
Baseline, 4th week, 8th week and 12th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barrat Impulsivity Scale (BIS 11)
Time Frame: 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.
|
Baseline, 4th week, 8th week and 12th week
|
|
Hypersexual Disorder Screening Inventory (HDSI)
Time Frame: 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.
|
Baseline, 4th week, 8th week and 12th week
|
|
Beck Anxiety Inventory (BAI)
Time Frame: 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.
|
Baseline, 4th week, 8th week and 12th week
|
|
Beck Depression Inventory (BDI)
Time Frame: 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.
|
Baseline, 4th week, 8th week and 12th week
|
|
World Health Organization Quality of Life (WHOQOL-bref)
Time Frame: Baseline and 12th week
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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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marco Scanavino, PHD, University of Sao Paulo General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30117919.5.0000.0068
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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