Yoga Intervention Practice as a Complementary and Integrative Treatment for Compulsive Sexual Behavior Disorder: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sexual Compulsivity Scale (SCS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Volunteers, health care professionals and researchers will not have access to randomization and will also not know which intervention group they were assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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);
- •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.
排除标准
- •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.
结局指标
主要结局
Sexual Compulsivity Scale (SCS)
时间窗: 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.
次要结局
- 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)
- Barrat Impulsivity Scale (BIS 11)(Baseline, 4th week, 8th week and 12th week)
- 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)