NCT06014281

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

August 23, 2023

Last Update Submit

May 19, 2025

Conditions

HealthyWell-Being, Psychological

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (7)

  • Change in Stress Scale Measure Questionnaire Score

    Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)

  • Change in Depression Questionnaire Score

    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

    Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)

  • Change Social Connectedness Scale-Revised Questionnaire Score

    Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)

  • Change in Rumination Reflection Questionnaire Score

    Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: SOS Meditation

Interventions

SOS MeditationBEHAVIORAL

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.

Meditation groupWaitlist control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Psychiatry, Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Manish Saggar, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 28, 2023

Study Start

November 1, 2023

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)