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Completed

NCT Number: NCT06551467

Effect of an Innovative Online Ayurveda Program on the Mental and Physical Health of Home-Based Adults

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Maharishi AyurVeda and Holistic Medicine

Geboltskirchen, 4682, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Ayurveda Program for Detox and Lifestyle

Behavioral

The program includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices.

Primary outcomes

  1. Change in Anxiety Score

    Time frame: 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.

  2. Change in Depression Score

    Time frame: 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 outcomes

  1. Change in Somatic or Physical Symptoms Score Change in Somatic or Physical Symptoms Score

    Time frame: 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.

  2. Change in Fatigue Score

    Time frame: 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.

  3. Changes in Body Mass Index (BMI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maharishi International University

Other

Registry information

Official study title

Feasibility Trial of an Innovative Online Ayurveda Program for Detox and Lifestyle: Effect on Mental and Physical Health in Home-Based Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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