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

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06014281
Collaborator
Institute for Meditation and Inner Harmony (Other), Feldman Foundation CA (Other)
200
1
2
15
13.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SOS Meditation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Generalize Anxiety Disorder Questionnaire Score [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 [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 [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 [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 [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 [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 [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 Outcome Measures

  1. Change in Stress Scale Measure Questionnaire Score [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Psychiatry, Stanford University Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University
  • Institute for Meditation and Inner Harmony
  • Feldman Foundation CA

Investigators

  • Principal Investigator: Manish Saggar, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Manish Saggar, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT06014281
Other Study ID Numbers:
  • 68784
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 28, 2023