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Examining the Effects of Reduced Environmental Stimulation on Anxiety

Primary Purpose

Generalized Anxiety Disorder, Agoraphobia, Panic Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Floating

Comparison

About this trial

This is an interventional basic science trial for Generalized Anxiety Disorder focused on measuring Anxiety, Floating

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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:
1. Schizophrenia Spectrum and Other Psychotic Disorders
2. 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.

Sites / Locations

Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Floating

Comparison condition

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood pressure changes during the float experience

Heart rate variability changes during the float experience

EEG changes during the float experience

Brain activation and connectivity changes from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)

Bioassay changes in magnesium, sulfate, cortisol, and inflammatory markers

Blood and urine samples

Subjective changes in emotion and mood

Examining pre- to post-float change scores on various self-report measures (e.g., PANAS-X)

Full Information

NCT ID

NCT03051074

First Posted

January 9, 2017

Last Updated

October 4, 2023

Sponsor

Laureate Institute for Brain Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03051074

Brief Title

Examining the Effects of Reduced Environmental Stimulation on Anxiety

Official Title

Examining the Effects of Reduced Environmental Stimulation on Anxiety

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laureate Institute for Brain Research, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Anxiety, Floating

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Floating

Arm Type

Experimental

Arm Description

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

Arm Title

Comparison condition

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Floating

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Comparison

Intervention Description

Watching a relaxing film for up to 90 minutes

Primary Outcome Measure Information:

Title

Spielberger State Anxiety Inventory (STAI-S) change score

Description

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)

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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)

Title

Bioassay changes in magnesium, sulfate, cortisol, and inflammatory markers

Description

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

Title

Subjective changes in emotion and mood

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justin Feinstein, PhD

Organizational Affiliation

Laureate Institute for Brain Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laureate Institute for Brain Research

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29394251

Citation

Feinstein JS, Khalsa SS, Yeh HW, Wohlrab C, Simmons WK, Stein MB, Paulus MP. Examining the short-term anxiolytic and antidepressant effect of Floatation-REST. PLoS One. 2018 Feb 2;13(2):e0190292. doi: 10.1371/journal.pone.0190292. eCollection 2018.

Results Reference

derived

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Examining the Effects of Reduced Environmental Stimulation on Anxiety

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