跳至主要内容
临床试验/CTRI/2021/11/037826
CTRI/2021/11/037826Not Applicable不适用

VALIDATION OF AN INTEGRATED YOGA MODULE AS AN ADJUNCT FOR THE MANAGEMENT OF SUBSTANCE USE DISORDER.

Yantra Atmika Ramsahaye Maraz1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月11日最近更新:

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
30
试验地点
1
主要终点
1. Development an Integrated Yoga Module for Substance Use Disorder

研究概览

简要总结

This study’s objective is to develop, validate and assess the feasibility of an Integrated Yoga Module as an adjunct for the management of substance use disorder.

For the development of the module, we are taking support from ancient and modern literature. The validation will be done by following the Delphi method of iteration with international experts in the field of yoga, psychology, psychiatry, social work as well as stake holders. The feasibility of the study will be assessed by doing a pilot study at the Centre d’Accueil de Terre Rouge (Mauritius). The Integrated Yoga Module will be done on an experimental group in addition with the Treatment as Usual.  The control group will be given Treatment as Usual. Anthropomorphic details, symptoms of Substance Use Disorder, motivation and quality of life levels will be assessed for both the groups, pre-intervention, post-intervention(4 weeks) and after one month. Changes will be made to the Integrated Yoga Module as per the inputs of participants.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Male

入选标准

  • Individuals who have been diagnosed by a Psychiatrist with New Psychoactive Drugs, or Opiates and Opioids or Polysubstance Use /Other Unknown substances dependence.
  • Individuals who are males above 18-45 years old Having medical clearance to participate Individuals who are fluent in either French or Creole or English.
  • Individuals who have undergone medically supervised detoxification at the CATR rehabilitation center.

排除标准

  • 1.Individuals who have been diagnosed with psychotic disorders like schizophrenia.
  • 2.Individuals with acute withdrawal symptoms as assessed by a Psychiatrist 3.Individuals with acute suicidality or possibility of being of imminent dangers to others 4.Individuals needing intensive treatment due to high risk of relapse or continued heavy use, as determined by a Psychiatrist.

结局指标

主要结局

1. Development an Integrated Yoga Module for Substance Use Disorder

时间窗: Estimated time : | 10.01.22- baseline assessment | 5.02.22- 4th week assessment | 25.02.22- 8th week assessment

2. Validation of the Integrated Yoga Module for Substance Use Disorder

时间窗: Estimated time : | 10.01.22- baseline assessment | 5.02.22- 4th week assessment | 25.02.22- 8th week assessment

3. Parameters at each 3 time point- Changes in symptoms of Substance Use disorder- motivation, overall health and quality of life

时间窗: Estimated time : | 10.01.22- baseline assessment | 5.02.22- 4th week assessment | 25.02.22- 8th week assessment

次要结局

  • A pilot testing of the Integrated Yoga Module to assess the feasibility of the module(Secondary outcomes for each 3 assessment period- Assessing the Guna (Vedic personality) and Anthropomorphic Assessment- Respiratory rate, BMI, Brahmari rate, Blood pressure.)

研究者

发起方
Yantra Atmika Ramsahaye Maraz
申办方类型
Other [self-funding]

研究点 (1)

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