Generalized Anxiety Disorder, Agoraphobia, Panic Disorder, PostTraumatic Stress Disorder, Social Anxiety Disorder, Major Depressive Disorder
Conditions
Keywords
Anxiety, Floating
Brief summary
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.
Detailed description
The human brain is constantly bombarded with sensory information from the external world. This series of studies aim to explore the effects of reducing environmental stimulation using specially designed floatation pools that minimize visual, auditory, tactile, proprioceptive, and thermal input to the brain. Previous research has shown that floating in this unique setting can significantly reduce levels of anxiety, stress, blood pressure, and cortisol, while significantly increasing levels of both subjective and physiological forms of relaxation. Much of this past research contained various methodological weaknesses, including small sample sizes and lack of a control condition. Moreover, very little is known about the potential benefits of floating in clinical populations, and essentially nothing is known about the effects of floating on the brain. The studies proposed in this protocol aim to further explore floating's potentially salubrious effect on the autonomic nervous system, while beginning to investigate its largely unknown effect on the central nervous system. The researchers have attempted to improve upon the weaknesses of past research by using larger sample sizes and a control condition. The current project is focused on documenting the subjective, physiological and neural effects of floating in healthy and anxious populations. The subjective effects of floating will be examined using self-report measures and the experience sampling method. The physiological effects of floating will be examined using waterproof and wireless tracking of blood pressure, heart rate, respiration, and movement, in addition to collecting measures of cortisol and magnesium. The neural effects of floating will be examined using waterproof and wireless EEG collected during the float experience, as well as using functional magnetic resonance imaging (fMRI) collected before and immediately after floating. An exteroceptive control condition aims to examine each participant's baseline physiological state while participants watch a neutral documentary film. This program of research constitutes the first systematic investigation of floating on the body and the brain, and the findings have the potential to illuminate the physiological and neural correlates of the relaxation response induced by the floating experience.
Interventions
BEHAVIORALFloating
Floating supine in a pool saturated with Epsom salt for up to 90 minutes
BEHAVIORALComparison
Watching a relaxing film for up to 90 minutes
Sponsors
Laureate Institute for Brain Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
On the 2nd session, participants will be randomly assigned to start in the pool condition or comparison condition. Following a 1-week washout period, they will crossover to the other condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
for anxious subjects: 1. Overall Anxiety Severity and Impairment Scale (OASIS) score ≥ 8 2. Anxiety Sensitivity Index 3 (ASI-3) score of ≥ 29 3. Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of an anxiety disorder or PTSD as determined by the Mini International Neuropsychiatric Interview (MINI Version 6.0) 4. Comorbid conditions are acceptable (except those listed in the
Exclusion criteria
). Inclusion Criteria for healthy subjects: 1. Overall Anxiety Severity and Impairment Scale (OASIS) score \< 4 2. Anxiety Sensitivity Index 3 (ASI-3) score \< 13 3. No DSM-V diagnoses as determined by the Mini International Neuropsychiatric Interview (MINI Version 6.0) and no history of neurological or psychiatric issues.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spielberger State Anxiety Inventory (STAI-S) change score | The investigators will calculate the pre- to post-float change score following each session (up to 3 float sessions + 1 comparison session completed over a 1 year time period; each session will be spaced apart by a minimum of 7 days) | A valid and reliable psychological inventory consisting of 20 self-report items pertaining to state anxiety. The investigators will calculate pre- to post-float change scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability changes during the float experience | These measures will be acquired during the 2nd and 3rd float sessions + comparison session completed over a 1 year time period, with each session spaced apart by a minimum of 7 days | — |
| EEG changes during the float experience | EEG will be acquired during the 2nd and 3rd float sessions + comparison session completed over a 1 year time period, with each session spaced apart by a minimum of 7 days | — |
| Blood pressure changes during the float experience | These measures will be acquired during the 2nd float session and comparison session, with each session spaced apart by a minimum of 7 days | — |
| Bioassay changes in magnesium, sulfate, cortisol, and inflammatory markers | Samples will be acquired before and after the 2nd and 3rd float sessions + comparison session completed over a 1 year time period, with each session spaced apart by a minimum of 7 days | Blood and urine samples |
| Subjective changes in emotion and mood | Self-report measures acquired before and after each session (3 float sessions + comparison session completed over a 1 year time period, with each session spaced apart by a minimum of 7 days) | Examining pre- to post-float change scores on various self-report measures (e.g., PANAS-X) |
| Brain activation and connectivity changes from pre- to post-float as measured with functional magnetic resonance imaging (fMRI) | fMRI will be acquired immediately before and after the 3rd float session (completed over a 1 day time period) | — |
Countries
United States
Outcome results
None listed