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

Feasibility Trial of an Innovative Online Ayurveda Program for Detox and Lifestyle: Effect on Mental and Physical Health in 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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Online Ayurveda Program for Detox and Lifestyle

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Geboltskirchen, Austria, 4682
    • The Center for Maharishi AyurVeda and Holistic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The Online Ayurveda Program for Detox and Lifestyle Intervention Group will be divided into three individual psychophysiological Dosha-specific treatment groups. Participants will be assigned to these groups based on their results from the Ayurveda Dosha Self-Assessment questionnaire.	Behavioral: Online Ayurveda Program for Detox and Lifestyle; The program includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Score	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.	Assessed at baseline and once a month for four months
Change in Depression Score	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.	Assessed at baseline and once a month for four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Somatic or Physical Symptoms Score Change in Somatic or Physical Symptoms Score	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.	Assessed at baseline and once a month for four months
Change in Fatigue Score	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.	Assessed at baseline and once a month for four months
Changes in Body Mass Index (BMI)	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.	Assessed at baseline and once a month for four months

Collaborators and Investigators

• Sponsor: Maharishi International University
• Investigators: Principal Investigator: Viktoria Luhaste, PhD, Maharishi International University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: AYU-108-MIU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research data supporting this study's findings are not publicly accessible due to privacy and ethical constraints related to patient consent. However, anonymized data may be available from the authors upon request with permission from the institutional review board of Maharishi International University, Fairfield, Iowa.
• IPD Sharing Time Frame: IPD will be available six months after the study results are published in a peer-reviewed journal and will be accessible for up to three years after that.
• IPD Sharing Access Criteria: Researchers must submit a methodologically sound proposal for review by the data-sharing committee and the institutional review board of Maharishi International University, Fairfield, Iowa. The committee will approve access, and a data use agreement must be signed prior to data release.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No