An interventional study of Floating and Comparison in Generalized Anxiety Disorder, Agoraphobia and Panic Disorder, sponsored by Laureate Institute for Brain Research, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Laureate Institute for Brain Research, Inc. · Not applicable, Interventional, and Basic science
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Laureate Institute for Brain Research, Inc. is the lead sponsor of 54 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for anxious subjects:
Inclusion Criteria for healthy subjects:
Exclusion Criteria:
Has any of the following DSM-V disorders:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participant will float supine in water with a high concentration of Epsom salt for up to 90 minutes on three separate occasions
Behavioral: Floating
The participant will watch a relaxing 90 minute film as a comparison condition
Behavioral: Comparison
Floating supine in a pool saturated with Epsom salt for up to 90 minutes
Watching a relaxing film for up to 90 minutes
Spielberger State Anxiety Inventory (STAI-S) change score
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.
Time frame: 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)
Blood pressure changes during the float experience
Time frame: These measures will be acquired during the 2nd float session and comparison session, with each session spaced apart by a minimum of 7 days
Heart rate variability changes during the float experience
Time frame: 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
Time frame: 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
Brain activation and connectivity changes from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)
Time frame: fMRI will be acquired immediately before and after the 3rd float session (completed over a 1 day time period)
Bioassay changes in magnesium, sulfate, cortisol, and inflammatory markers
Blood and urine samples
Time frame: 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
Subjective changes in emotion and mood
Examining pre- to post-float change scores on various self-report measures (e.g., PANAS-X)
Time frame: 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)
Plan to share: No
Ran from Dec 2016 to primary completion in Dec 2019, 36 months.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 36 months is above that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
Laureate Institute for Brain Research, Inc.