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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014281
• Other study ID #: 68784
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Dept. of Psychiatry, Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Feldman Foundation CA, Institute for Meditation and Inner Harmony

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)