AnxietyNCT06551467
Effect of an Innovative Online Ayurveda Program on the Mental and Physical Health of Home-Based Adults
A study testing Online Ayurveda Program for Detox and Lifestyle in people with Anxiety and Depression, run by Maharishi International University at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Online Ayurveda Program for Detox and Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteAustria
- Study dates
- 10 Mar 2021to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
The Center for Maharishi AyurVeda and Holistic Medicine
Geboltskirchen, 4682
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Online Ayurveda Program for Detox and Lifestyle
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Ayurveda Program for Detox and LifestyleBehavioural
The program includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Ayurveda Program for Detox and Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline and once a month for four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start10 Mar 2021
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Viktoria Luhaste, Maharishi International University
- Investigators
- Viktoria Luhaste, PhD, Principal investigator, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551467
- Sponsor's protocol ID
- AYU-108-MIU
- Status last verified
- Dec 2024
- First submitted
- 9 Aug 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of an Innovative Online Ayurveda Program for Detox and Lifestyle: Effect on Mental and Physical Health in Home-Based Adults
- ClinicalTrials.gov ID
- NCT06551467
- Acronym / sponsor ID
- AYU-108-MIU
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Online Ayurveda Program for Detox and LifestyleThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Ayurveda Program for Detox and LifestyleThe program includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices. | Behavioural | Intervention Group |
Primary outcome
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.
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.
3 secondary outcomes
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
Change in Fatigue Score
Time frame: Assessed at baseline and once a month for four months
Changes in Body Mass Index (BMI)
Time frame: Assessed at baseline and once a month for four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktoria Luhaste, PhD principal investigator
Maharishi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Ayurveda Program for Detox and Lifestyle in people with Anxiety and Depression, run by Maharishi International University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Score (time frame: Assessed at baseline and once a month for four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.