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Набор по приглашению NCT04634175

Yoga Intervention for Compulsive Sexual Behavior Disorder

Без фазы С лечением Compulsive Sexual Behavior

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Yoga intervention, Sham intervention.
Кому может быть актуально
Состояния в реестре: Compulsive Sexual Behavior. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT04634175 · 30117919.5.0000.0068

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗