Feasibility Trial of an Innovative Online Ayurveda Program for Detox and Lifestyle: Effect on Mental and Physical Health in Home-Based Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Change in Anxiety Score
研究概览
简要总结
The overall objective of this study is to evaluate the effects, feasibility, and safety of a comprehensive online Ayurveda whole-systems (WS) intervention that targets the underlying etiological factors influencing mental and physical health symptoms. The primary hypothesis is that home-based adults who participate in the Ayurveda Program for Detox and Lifestyle will experience a decrease in anxiety and depression symptoms over 4 months.
详细描述
Two Ayurveda-trained medical doctors will lead the Online Ayurveda Program for Detox and Lifestyle, which comprises eight interactive live webinars over ten days. Each 1.5-hour session includes online group meetings focused on addressing the etiological factors contributing to mental and physical ill-health. The program is easily replicable and includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices, all based on traditional Ayurvedic medicine principles. After the ten-day detoxification, participants will continue to follow the diet and lifestyle recommendations and the herbal program for mental and physical health for up to four months. Outcome measures will be assessed at baseline and once a month for four months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scored ≥ 5 on the GAD-7
- •Scored ≥ 5 on the PHQ-9
- •Scored ≥ 5 on the PHQ-15
- •Age 18-80 years
- •No other psychiatric disorders
- •Not receiving specialized treatments for anxiety or depression, nor participating in another clinical trial
- •Stable psychiatric medication regimen for more than two months
- •No acute or severe medical conditions
- •Individuals who are not pregnant or breastfeeding
- •Provided informed consent
排除标准
- •Scored < 5 on the GAD-7
- •Scored < 5 on the PHQ-9
- •Scored < 5 on the PHQ-15
- •Age under 18 or over 80 years
- •Other psychiatric disorders (e.g., suicidal risk)
- •Currently undergoing specialized treatments for anxiety and depression, or participating in another clinical trial
- •Psychiatric medication regimen for less than 2 months
- •Acute or severe medical condition (e.g., stroke, surgery)
- •Individuals who are pregnant or breastfeeding
- •Inability to provide informed consent
结局指标
主要结局
Change in Anxiety Score
时间窗: Assessed at baseline and once a month for four months
Assessed using the online standardized Patient Health Questionnaire for Somatic, Anxiety, and Depressive Symptoms (PHQ-SADS). The PHQ-SADS uses cut-off points of 5, 10, and 15 to represent mild, moderate, and severe symptoms, respectively. The assessment includes the Generalized Anxiety Disorder 7-item (GAD-7) scale, which measures the severity of anxiety. The GAD-7 uses cut-off points of 5, 10, and 15 for mild, moderate, and severe anxiety, respectively. The scale ranges from 0 to 21, with higher scores indicating greater anxiety levels.
Change in Depression Score
时间窗: Assessed at baseline and once a month for four months
Assessed using the online standardized Patient Health Questionnaire for Somatic, Anxiety, and Depressive Symptoms (PHQ-SADS). The PHQ-SADS uses cut-off points of 5, 10, and 15 to represent mild, moderate, and severe symptoms, respectively. The assessment also includes the Patient Health Questionnaire-9 (PHQ-9) for depression, which uses cut-off points of 5, 10, 15, and 20 to represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 scale ranges from 0 to 27, with higher scores indicating greater severity of depression.
次要结局
- Change in Somatic or Physical Symptoms Score Change in Somatic or Physical Symptoms Score(Assessed at baseline and once a month for four months)
- Change in Fatigue Score(Assessed at baseline and once a month for four months)
- Changes in Body Mass Index (BMI)(Assessed at baseline and once a month for four months)
研究者
Dr. Viktoria Luhaste
Principal Investigator, Department of Physiology and Health
Maharishi International University