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NCT Number: NCT06014281

Examining the Effects of Regular Brief Internet-based 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Behavior Personal Satisfaction Psychological Well-Being Well-Being, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Psychiatry, Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOS Meditation

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.

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

Secondary outcomes

  1. 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)

    Stress measured using Perceived Stress Scale measure

  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)

    Depression measured using Patient Health Questionnaire

  3. 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)

    Quality of life measured using Quality of Life Scale measures

  4. 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)

    Social Connectedness measured using Social Connectedness Scale-Revised

  5. 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)

    Rumination and reflection scales measured using Rumination Reflection Questionnaire

  6. 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)

    Strengths scale measured using Brief Strengths Scale measures individuals' Temperance Strength, Intellectual Strength, and Interpersonal Strength.

  7. 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)

    Daily obtained from Activity Tracker wrist band

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Feldman Foundation CA
  • Institute for Meditation and Inner Harmony

Registry information

Official study title

An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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