Healthy, Well-Being, Psychological
Conditions
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.
Interventions
BEHAVIORALSOS 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.
Sponsors
Institute for Meditation and Inner Harmony
Feldman Foundation CA
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
Countries
United States
Outcome results
None listed