Examining the Effects of Reduced Environmental Stimulation on Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mechanisms of Treatment Change in Panic Disorder and Agoraphobia

NCT03547180

Panic Disorder With Agoraphobia

COMPLETED NA

Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder

NCT03683472

Anxiety Disorders

COMPLETED NA

Predicting Treatment Response to Exposure Therapy Using Carbon Dioxide

NCT03925987

Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder +1 more

COMPLETED NA

Modulating Context Generalization Through Transcranial Direct Current Stimulation

NCT03374605

Anxiety and Fear

WITHDRAWN NA

Neurobiology of Generalized Fear-Conditioning & Avoidance in Anxiety Disorders

NCT03033056

Anxiety Disorders

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Generalized Anxiety Disorder Agoraphobia Panic Disorder PostTraumatic Stress Disorder Social Anxiety Disorder Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Floating

The participant will float supine in water with a high concentration of Epsom salt for up to 90 minutes on three separate occasions

Group Type EXPERIMENTAL

Floating

Intervention Type BEHAVIORAL

Floating supine in a pool saturated with Epsom salt for up to 90 minutes

Comparison condition

The participant will watch a relaxing 90 minute film as a comparison condition

Group Type ACTIVE_COMPARATOR

Comparison

Intervention Type BEHAVIORAL

Watching a relaxing film for up to 90 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Floating

Floating supine in a pool saturated with Epsom salt for up to 90 minutes

Intervention Type BEHAVIORAL

Comparison

Watching a relaxing film for up to 90 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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)

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.

Exclusion Criteria

1. Has any of the following DSM-V disorders:

1. Schizophrenia Spectrum and Other Psychotic Disorders
2. Bipolar and Related Disorders
2. Is currently being treated for their psychiatric condition as an inpatient
3. Active suicidal ideation with intent or plan
4. Participant is morbidly obese (BMI \> 40) or underweight (BMI \< 17).
5. 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).
6. 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.
7. Pregnancy as detected by a urine test.
8. Non-correctable vision or hearing problems.
9. 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).
10. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes