HealthyNCT06014281
Examining the Effects of Regular Brief Internet-based Meditation Practice on Mental Health and Well Being
A study testing SOS Meditation in people with Healthy and Well-Being, Psychological, run by Stanford University at 1 site in United States.
Trial summary
The study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Well-Being, Psychological
- What is being tested?
- SOS Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Able to follow basic instructions for prescreening and scheduling
- Compliant with investigator instructions during the consent process and participation in the study
- Is not already a regular meditation practitioner
Who cannot join
- Age <18
- People with a current diagnosis of psychiatric or neurological disorders
- Be in current psychiatric treatment or medications
- Hospitalized for psychiatric disorders in the past year or so.
- Regular and long-term meditation practitioners
- Non-English speaking
- Non-USA mailing address to receive the activity tracker device
- Vision or hearing impairment severe enough to interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept. of Psychiatry, Stanford University
Stanford, California, 94305
About this study
Official title: An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being
The study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures.
Read the detailed description
This is a 16-week study with an 8-week meditation intervention, with a requirement of a minimum of 10 minutes of meditation practice each day. This study will recruit ~200 healthy subjects (18+ years) with no current or previous diagnosis of psychiatric or neurological disorders who are interested in learning about meditation but don't have long-term experience with meditation. Half of the participant pool will be randomly assigned to the meditation intervention, and the other half will get the wait-list control assignment. The control group will later receive its intervention, likely a few weeks after the completion of the active group's intervention. A focused-attention meditation technique (SOS meditation) will be used to train participants.
Changes in participants' physiological markers (e.g., HRV, physical activity, respiration rate, sleep quality) will be evaluated using passive activity monitoring devices (e.g., Fitbit). Intervention-related changes in mental health will be assessed using web-based mental health and well-being surveys. Improvements in cognitive functioning will be assessed using web-based psychological tasks.
- Conditions
- Healthy, Well-Being, Psychological
- Being tested
- SOS Meditation
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOS MeditationBehavioural
Focused-attention meditation technique will be used to train participants, specifically the SOS meditation technique. The SOS meditation technique is an easy-to-learn approach where participants are instructed to dissociate their attention from physical awareness, thoughts, and emotions by mentally slowly repeating a calming word or phrase (chosen by the participant themselves).
SOS Meditation Instructions:
- Close your eyes very gently, in a relaxed way, as you do when we go to sleep
- Your attention should be fully alert. Try not to put any strain on your eyes or try to look up.
- Focus your eyes about eight to ten inches into the field of darkness in front of you on the horizontal plane
- Mentally repeat the (chosen) calming word
- Sit lovingly and calmly to see what comes up, as if you were watching a movie screen and waiting to see what appears on it.
| Study group | Role | What they receive |
|---|---|---|
| Meditation group | Experimental | Baseline to week 8:
Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed.
Week 8 to week 16:
Subjects will self report if they choose to continue SOS meditation and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the impact of continued meditation practice on mental health and well being. Receives: Behavioral: SOS Meditation |
| Waitlist control | Experimental | Baseline to week 8:
Subjects will be place in a control group which receives no intervention. However, several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess baseline mental health and well being scores.
Week 8 to week 16:
Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed. Receives: Behavioral: SOS Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Generalize Anxiety Disorder Questionnaire Score
Anxiety as measured using Generalize Anxiety Disorder Questionnaire
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Pittsburgh Sleep Quality Index Questionnaire Score
Sleep Quality measured using Pittsburgh sleep quality index (PSQI)
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Mind Wandering Questionnaire Score
Mind wandering measured using the Mind Wandering Questionnaire
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Resting Heart Rate
Daily obtained from Activity Tracker wrist band
Measured: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Heart Rate Variability
Daily obtained from Activity Tracker wrist band
Measured: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Change in Stroop Test Score
Using the Stroop test, which measures the average reaction time between incongruent and congruent trials
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in N-back Test Score
Using the N-back test is a memory task where participants must remember letters from N trials ago.
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Secondary outcomes (7)
Change in Stress Scale Measure Questionnaire Score
Stress measured using Perceived Stress Scale measure
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Depression Questionnaire Score
Depression measured using Patient Health Questionnaire
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Quality of Life Scale Measures Questionnaire Score
Quality of life measured using Quality of Life Scale measures
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change Social Connectedness Scale-Revised Questionnaire Score
Social Connectedness measured using Social Connectedness Scale-Revised
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Rumination Reflection Questionnaire Score
Rumination and reflection scales measured using Rumination Reflection Questionnaire
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Brief Strengths Scale Questionnaire Score
Strengths scale measured using Brief Strengths Scale measures individuals' Temperance Strength, Intellectual Strength, and Interpersonal Strength.
Measured: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Sleep Quality Measure
Daily obtained from Activity Tracker wrist band
Measured: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Meditation and Inner Harmony, Feldman Foundation CA
- Responsible party
- Principal investigator, Manish Saggar, Stanford University
- Investigators
- Manish Saggar, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014281
- Sponsor's protocol ID
- 68784
- Status last verified
- May 2025
- First submitted
- 23 Aug 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being
- ClinicalTrials.gov ID
- NCT06014281
- Acronym / sponsor ID
- 68784
- Conditions
- Healthy, Well-Being, Psychological
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Institute for Meditation and Inner Harmony, Feldman Foundation CA
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 28 Aug 2023 (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 study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures.
Detailed description
This is a 16-week study with an 8-week meditation intervention, with a requirement of a minimum of 10 minutes of meditation practice each day. This study will recruit ~200 healthy subjects (18+ years) with no current or previous diagnosis of psychiatric or neurological disorders who are interested in learning about meditation but don't have long-term experience with meditation. Half of the participant pool will be randomly assigned to the meditation intervention, and the other half will get the wait-list control assignment. The control group will later receive its intervention, likely a few weeks after the completion of the active group's intervention. A focused-attention meditation technique (SOS meditation) will be used to train participants.
Changes in participants' physiological markers (e.g., HRV, physical activity, respiration rate, sleep quality) will be evaluated using passive activity monitoring devices (e.g., Fitbit). Intervention-related changes in mental health will be assessed using web-based mental health and well-being surveys. Improvements in cognitive functioning will be assessed using web-based psychological tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation group | Experimental | Behavioral: SOS MeditationBaseline to week 8: Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed. Week 8 to week 16: Subjects will self report if they choose to continue SOS meditation and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the impact of continued meditation practice on mental health and well being. |
| Waitlist control | Experimental | Behavioral: SOS MeditationBaseline to week 8: Subjects will be place in a control group which receives no intervention. However, several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess baseline mental health and well being scores. Week 8 to week 16: Subjects will be trained to meditate for 10 minutes daily, and several measures (questionnaires, cognitive tests, and physiological measurements) will be obtained to assess the efficacy of daily meditation practice on mental health and well being. Focused-attention meditation technique will be used to train participants. Specifically the SOS meditation technique will be employed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Able to follow basic instructions for prescreening and scheduling
- Compliant with investigator instructions during the consent process and participation in the study
- Is not already a regular meditation practitioner
Key exclusion criteria (8 listed)
- Age <18
- People with a current diagnosis of psychiatric or neurological disorders
- Be in current psychiatric treatment or medications
- Hospitalized for psychiatric disorders in the past year or so.
- Regular and long-term meditation practitioners
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 |
|---|---|---|
| SOS MeditationFocused-attention meditation technique will be used to train participants, specifically the SOS meditation technique. The SOS meditation technique is an easy-to-learn approach where participants are instructed to dissociate their attention from physical awareness, thoughts, and emotions by mentally slowly repeating a calming word or phrase (chosen by the participant themselves). SOS Meditation Instructions: * Close your eyes very gently, in a relaxed way, as you do when we go to sleep * Your attention should be fully alert. Try not to put any strain on your eyes or try to look up. * Focus your eyes about eight to ten inches into the field of darkness in front of you on the horizontal plane * Mentally repeat the (chosen) calming word * Sit lovingly and calmly to see what comes up, as if you were watching a movie screen and waiting to see what appears on it. | Behavioural | Meditation group, Waitlist control |
Primary outcome
Change in Generalize Anxiety Disorder Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Anxiety as measured using Generalize Anxiety Disorder Questionnaire
Change in Pittsburgh Sleep Quality Index Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Sleep Quality measured using Pittsburgh sleep quality index (PSQI)
Change in Mind Wandering Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Mind wandering measured using the Mind Wandering Questionnaire
Resting Heart Rate
Time frame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Daily obtained from Activity Tracker wrist band
Heart Rate Variability
Time frame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Daily obtained from Activity Tracker wrist band
Change in Stroop Test Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Using the Stroop test, which measures the average reaction time between incongruent and congruent trials
Change in N-back Test Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Using the N-back test is a memory task where participants must remember letters from N trials ago.
7 secondary outcomes
Change in Stress Scale Measure Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Depression Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Quality of Life Scale Measures Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change Social Connectedness Scale-Revised Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Rumination Reflection Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Brief Strengths Scale Questionnaire Score
Time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Change in Sleep Quality Measure
Time frame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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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.
Manish Saggar, PhD principal investigator
Stanford 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 SOS Meditation in people with Healthy and Well-Being, Psychological, run by Stanford University at 1 site in United States.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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 Generalize Anxiety Disorder Questionnaire Score (time frame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)). The study lists 7 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 22 May 2025.