Examining the Effects of Regular Brief Internet-based Meditation Practice on Mental Health and Well Being

NCT ID: NCT06014281

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-07-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meditation group

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.

Group Type: EXPERIMENTAL

SOS Meditation

Intervention Type: BEHAVIORAL

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.

Waitlist control

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.

Group Type: EXPERIMENTAL

SOS Meditation

Intervention Type: BEHAVIORAL

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.

Interventions

SOS Meditation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Meditation and Inner Harmony

UNKNOWN

Sponsor Role: collaborator

Feldman Foundation CA

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Manish Saggar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manish Saggar, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Dept. of Psychiatry, Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

68784

Identifier Type: -

Identifier Source: org_study_id