The Add-on Effect of Tele-Yoga on Generalized Anxiety Disorder: A Randomized Controlled Trial on Efficacy and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- i. To examine the effects of add-on tele-yoga intervention on the severity of anxiety symptoms on GADSS and CGI-I
研究概览
简要总结
The current study aims atassessing the effect of 8-week tele- yoga intervention on the clinical outcomesin patients with generalized anxiety disorders.
AIM
To evaluate the effects of add-onTele-Yoga intervention in patients with Generalized Anxiety Disorder (GAD) onclinical outcomes and underlying mechanisms
PRIMARY OBJECTIVES
i. To assess the feasibility of the Teleadaptation of validated yoga module for GAD
ii. To examine the effects of add-on tele-yogaintervention on clinical outcomes in patients with GAD
SECONDARY OBJECTIVES
i. Toexamine the effects of add-on tele-yoga intervention on heart ratevariability during stress test in patients with GAD
ii. Toexamine the effects of add-on tele-yoga intervention on galvanic skinresponse during stress test in patients with GAD
iii. Toexamine the effects of add-on tele-yoga intervention on DLPFC functionalconnectivity using functional near infrared spectroscopy (fNIRS) in patientswith GAD
iv. Toexamine the effects of add-on tele-yoga intervention on salivarycortisol levels during stress test in patients with GAD
v. Toexamine the effects of add-on tele-yoga intervention on sleep quality (PSQI) inpatients with GAD
· Design:Randomized controlled assessor blind parallel arm trial
· Numberof groups: 2
Consecutive consentingeligible subjects with GAD will be randomly assigned to any one of the 2 groups(1:1 allocation ratio), using computer-generated random numbers
1) Interventiongroup [Tele-Yoga (TY) + standard care]: TY group
2) Controlgroup [Mental Health Education group + standard care]: MHE group
· Allocationconcealmentwill be assured by using sequentially numbered opaquesealed envelopes
· **Blinding:**assessorblinded; the rater will be blinded to reduce bias
· **Samplesize:**N=88 (44 each in experimental group and control group)
· Sampling: Convenientsampling
INCLUSION CRITERIA
• Out-patientsor in-patients with a primary psychiatric diagnosis of generalized anxietydisorder with or without co-morbid neurotic disorders
• 18years to 60 years of age
• Bothgender
• CGI-severityscore of 3 to 5
• Thosewith or without medications for GAD. If ON medication, current medication doseshould have been stable for a minimum of 4 weeks.
• Willingnessand ability to perform the yoga intervention and to comply with therequirements of the study protocol.
EXCLUSION CRITERIA
• Subjectswith primary diagnosis of other anxiety disorders excluding GAD
• Unableto understand study procedures and participate in the informed consent process.
• Subjectswho are currently on antipsychotics
• Seriousmedical illness and co-morbidities such as uncontrolled diabetes, hypertension,thyroid disorders.
• Significantcurrent suicidal ideation or suicidal behaviors within the past 6 months
• Posttraumaticstress disorder/substance use disorder (except nicotine)/eatingdisorder/organic mental disorders
• Psychoticdisorder, bipolar disorder, or developmental disorder
• Practice of yoga and meditation inlast 6 months.
• Concomitantpsychotherapy such as cognitive behavioral therapy
• Pregnantwomen
INTERVENTION
Yogagroup; a validated yoga module for anxiety disorders will be given 3 days aweek for 8 weeks through tele-mode
MentalHealth Education group: educational sessions on anxiety disorders will be given3 days a week for 8 weeks through tele-mode
OUTCOME MEASURES
-
Generalized anxiety disorder rating scale
-
Clinical global improvement
-
Heart rate variability
-
Galvanic skin resistance
-
Salivary cortisol levels
-
dorsolateral prefrontal connectivity through functional near-infrared spectroscopy
-
Pittsburg sleep quality index
-
Yoga Performance Assessment
The aboveassessments will be performed at the baseline and after 8 weeks of theintervention. data will be extracted and appropriate statistical analyses willbe performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Out-patients with a primary psychiatric diagnosis of generalized anxiety disorder with or without co-morbid neurotic disorders 2)CGI-severity score of 3 to 5 3)Those with or without medications for GAD.
- •If ON medication, current medication dose should have been stable for a minimum of 4 weeks.
- •Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.
排除标准
- •Subjects with primary diagnosis of other anxiety disorders excluding GAD 2)Unable to understand study procedures and participate in the informed consent process.
- •Subjects who are currently on anti psychotics 4)Serious medical illness and co-morbidities such as uncontrolled diabetes, hypertension, thyroid disorders.
- •Significant current suicidal ideation or suicidal behaviors within the past 6 months 6)Posttraumatic stress disorder/substance use disorder (except nicotine)/eating disorder/organic mental disorders 7)Psychotic disorder, bipolar disorder, or developmental disorder 8)Practice of yoga and meditation in last 6 months.
- •Concomitant psychotherapy such as cognitive behavioral therapy 10)Pregnant women.
结局指标
主要结局
i. To examine the effects of add-on tele-yoga intervention on the severity of anxiety symptoms on GADSS and CGI-I
时间窗: at baseline, 4 weeks and 8 weeks
scale
时间窗: at baseline, 4 weeks and 8 weeks
次要结局
- i.To examine the effects of add-on tele-yoga intervention on heart rate variability during triers stress test(ii.To examine the effects of add-on tele-yoga intervention on galvanic skin response during stress test)