Anxiety, Depression
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALOnline Ayurveda Program for Detox and Lifestyle
The program includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices.
Sponsors
Maharishi International University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study utilized a single-arm repeated-measures design to monitor changes in the online intervention over time and increase the precision of the outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Somatic or Physical Symptoms Score Change in Somatic or Physical Symptoms Score | 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 PHQ-15 scale, which assesses somatic symptoms. The PHQ-15 uses cut-off points of 5, 10, and 15 to represent mild, moderate, and severe somatic symptoms, respectively. The scale ranges from 0 to 30, with higher scores indicating greater severity of somatic symptoms. |
| Change in Fatigue Score | Assessed at baseline and once a month for four months | Fatigue was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (8a). The form uses a scale of 8 to 40, with higher scores indicating more significant fatigue. Scores of 22, 26, and 36 represent mild, moderate, and severe fatigue. |
| Changes in Body Mass Index (BMI) | Assessed at baseline and once a month for four months | Participants measured their height and weight using a standard scale and tape, and then reported these measurements in the online survey. Body Mass Index (BMI) was calculated using the standardized formula: weight (kg) / \[height (m)\]². The calculations were performed using an Excel program. |
Countries
Austria
Outcome results
None listed