Examining the Effects of Reduced Environmental Stimulation on Anxiety

NCT03051074 | Completed

• 1 other identifier: 2015-002 Float-Anxiety
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anxiety; Floating

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (6)

• 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

• 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

• 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)

• 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

Study Arms (2)

Floating

EXPERIMENTAL

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

Comparison condition

ACTIVE COMPARATOR

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

Behavioral: Comparison

Interventions

Floating BEHAVIORAL

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

Floating

Comparison BEHAVIORAL

Watching a relaxing film for up to 90 minutes

Comparison condition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (2)

• Flux MC, Fine TH, Poplin T, Al Zoubi O, Schoenhals WA, Schettler J, Refai HH, Naegele J, Wohlrab C, Yeh HW, Lowry CA, Levine JC, Smith R, Khalsa SS, Feinstein JS. Exploring the acute cardiovascular effects of Floatation-REST. Front Neurosci. 2022 Dec 9;16:995594. doi: 10.3389/fnins.2022.995594. eCollection 2022.

  PMID: 36570829 DERIVED

• 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.

  PMID: 29394251 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Agoraphobia; Panic Disorder; Stress Disorders, Post-Traumatic; Phobia, Social; Depressive Disorder, Major; Anxiety Disorders

Interventions

Divorce

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Justin Feinstein, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: February 13, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)