- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03051074
Examining the Effects of Reduced Environmental Stimulation on Anxiety
October 4, 2023 updated by: Sahib Khalsa, Laureate Institute for Brain Research, Inc.
The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Laureate Institute for Brain Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria for anxious subjects:
- Overall Anxiety Severity and Impairment Scale (OASIS) score ≥ 8
- Anxiety Sensitivity Index 3 (ASI-3) score of ≥ 29
- 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)
- Comorbid conditions are acceptable (except those listed in the exclusion criteria).
Inclusion Criteria for healthy subjects:
- Overall Anxiety Severity and Impairment Scale (OASIS) score < 4
- Anxiety Sensitivity Index 3 (ASI-3) score < 13
- No DSM-V diagnoses as determined by the Mini International Neuropsychiatric Interview (MINI Version 6.0) and no history of neurological or psychiatric issues.
Exclusion Criteria:
Has any of the following DSM-V disorders:
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
- Is currently being treated for their psychiatric condition as an inpatient
- Active suicidal ideation with intent or plan
- Participant is morbidly obese (BMI > 40) or underweight (BMI < 17).
- Certain drugs or medications consumed within the past week including any psychoactive drugs (e.g., MDMA, LSD, psilocybin, peyote, phencyclidine, ketamine). For all other medications, the participant will be required to be stably medicated prior to participation (defined as having taken the medication for 6 weeks or longer).
- Participant has a history of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
- Pregnancy as detected by a urine test.
- Non-correctable vision or hearing problems.
- Unwillingness or inability to complete any of the major aspects of the study protocol. However, failing to complete some individual aspects will be acceptable (e.g., being unwilling to answer individual items on a questionnaire).
- MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/ wires, or neuro/bio-stimulators (TENS unit), persons who have ever been a professional metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with metal dyes, unwillingness to remove body piercings, and pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Floating
The participant will float supine in water with a high concentration of Epsom salt for up to 90 minutes on three separate occasions
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Floating supine in a pool saturated with Epsom salt for up to 90 minutes
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Active Comparator: Comparison condition
The participant will watch a relaxing 90 minute film as a comparison condition
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Watching a relaxing film for up to 90 minutes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spielberger State Anxiety Inventory (STAI-S) change score
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)
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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.
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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These measures will be acquired during the 2nd float session and comparison session, with each session spaced apart by a minimum of 7 days
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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
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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
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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
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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
|
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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)
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fMRI will be acquired immediately before and after the 3rd float session (completed over a 1 day time period)
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Bioassay changes in magnesium, sulfate, cortisol, and inflammatory markers
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
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Blood and urine samples
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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
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Subjective changes in emotion and mood
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)
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Examining pre- to post-float change scores on various self-report measures (e.g., PANAS-X)
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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)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Justin Feinstein, PhD, Laureate Institute for Brain Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
January 9, 2017
First Submitted That Met QC Criteria
February 10, 2017
First Posted (Actual)
February 13, 2017
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 4, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-002 Float-Anxiety
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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