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

NCT06551467 | Completed

• 1 other identifier: AYU-108-MIU
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Online Ayurveda Program for Detox and Lifestyle BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharishi International University: lead

Study Sites (1)

The Center for Maharishi AyurVeda and Holistic Medicine

Geboltskirchen, 4682, Austria

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

detox adjuvant

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Viktoria Luhaste, PhD

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Physiology and Health

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: March 10, 2021
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

AU (1)