Clinical trial NCT06014281: Examining the Effects of Regular Brief Internet-based Meditation Practice on Mental Health and Well Being
Official title: An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Well-Being, Psychological
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Institute for Meditation and Inner Harmony
name: Feldman Foundation CA
First posted: 2023-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Generalize Anxiety Disorder Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in Pittsburgh Sleep Quality Index Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in Mind Wandering Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Resting Heart Rate
timeFrame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
measure: Heart Rate Variability
timeFrame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
measure: Change in Stroop Test Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in N-back Test Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
Secondary outcomes:
measure: Change in Stress Scale Measure Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in Depression Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in Quality of Life Scale Measures Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change Social Connectedness Scale-Revised Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in Rumination Reflection Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in Brief Strengths Scale Questionnaire Score
timeFrame: Twice (Baseline and week 8 for arm 1 and week 8 and week 16 for arm 2)
measure: Change in Sleep Quality Measure
timeFrame: Daily (from baseline to week 8 for arm 1 and from week 8 to week 16 for arm 2)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Dept. of Psychiatry, Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Manish Saggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: