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Mind-body Intervention for Compulsive Sexual Behavior Disorder (CSBD)

Primary Purpose

Compulsive Sexual Behavior

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mind-body intervention
Sham intervention
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compulsive Sexual Behavior focused on measuring Sexual Compulsion, Hypersexuality, Sex addiction, Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mind-body group

Sham group

Arm Description

The mind-body group will practice mind-body intervention.

The sham group will practice sham intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 11, 2020
Last Updated
April 11, 2022
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04634175
Brief Title
Mind-body Intervention for Compulsive Sexual Behavior Disorder
Acronym
CSBD
Official Title
Mind-Body Intervention Practice as a Complementary and Integrative Treatment for Compulsive Sexual Behavior Disorder: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
September 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compulsive Sexual Behavior
Keywords
Sexual Compulsion, Hypersexuality, Sex addiction, Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pre-test-post-test.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Volunteers, health care professionals and researchers will not have access to randomization and will also not know which intervention group they were assigned to.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mind-body group
Arm Type
Experimental
Arm Description
The mind-body group will practice mind-body intervention.
Arm Title
Sham group
Arm Type
Active Comparator
Arm Description
The sham group will practice sham intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mind-body intervention
Intervention Description
The mind-body intervention is composed of kundalini yoga techniques.
Intervention Type
Behavioral
Intervention Name(s)
Sham intervention
Intervention Description
The sham intervention is composed of stretching and muscle flexion techniques.
Primary Outcome Measure Information:
Title
Sexual Compulsivity Scale (SCS)
Description
Changes in the total score of Sexual Compulsivity Scale, the scores vary between 10 and 40, with the highest ones indicating greater sexual compulsiveness.
Time Frame
Baseline, 4th week, 8th week and 12th week
Secondary Outcome Measure Information:
Title
Barrat Impulsivity Scale (BIS 11)
Description
Changes in the total score of Barrat Impulsivity Scale, the scores vary between 1 and 30, with the highest ones indicating greater impulsivity.
Time Frame
Baseline, 4th week, 8th week and 12th week
Title
Hypersexual Disorder Screening Inventory (HDSI)
Description
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.
Time Frame
Baseline, 4th week, 8th week and 12th week
Title
Beck Anxiety Inventory (BAI)
Description
Changes in the total score of Beck Anxiety Inventory, the scores vary between 0 and 63, with the highest ones indicating greater anxiety.
Time Frame
Baseline, 4th week, 8th week and 12th week
Title
Beck Depression Inventory (BDI)
Description
Changes in the total score of Beck Depression Inventory, the scores vary between 0 and 63, with the highest ones meaning greater depression.
Time Frame
Baseline, 4th week, 8th week and 12th week
Title
World Health Organization Quality of Life (WHOQOL-bref)
Description
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.
Time Frame
Baseline and 12th week
Title
Sexual Inhibition Scale (SIS)
Description
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.
Time Frame
Baseline and 12th week
Title
Sexual Excitation Scale (SES)
Description
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.
Time Frame
Baseline and 12th week
Title
International Index of Erectile Function (IIFE)
Description
Changes in IIFE score, the scores are defined as absent, mild, moderate and severe, with the highest ones meaning greater dysfunction.
Time Frame
Baseline and 12th week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Scanavino, PHD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Psiquiatria do Hospital das Clínicas da Universidade de São Paulo[University of Sao Paulo General Hospital]
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

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Mind-body Intervention for Compulsive Sexual Behavior Disorder

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