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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Well-Being, Psychological
• Intervention / Treatment: Behavioral: SOS Meditation

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Dept. of Psychiatry, Stanford University
      • Contact: Manish Saggar, PhD; Phone Number: 650-723-3656; Email: braindynamicslab@stanford.edu
      • Principal Investigator: Manish Saggar, Ph.D.
      • Principal Investigator: David Spiegel, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Generalize Anxiety Disorder Questionnaire Score	Anxiety as measured using Generalize Anxiety Disorder Questionnaire	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)	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	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	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	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	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.	Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress Scale Measure Questionnaire Score	Stress measured using Perceived Stress Scale measure	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	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	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	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	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.	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	Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Institute for Meditation and Inner Harmony; Feldman Foundation CA
• Investigators: Principal Investigator: Manish Saggar, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 68784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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