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The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD (FLOAT)

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Medical College of Wisconsin

Status

Enrolling

Conditions

Post-Traumatic Stress Disorders

Treatments

Other: Floatation-based reduced environmental stimulation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04368689
PRO00032660

Details and patient eligibility

About

This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms.

Full description

This pilot study looks to further the current floatation-based REST literature by exploring the therapy's effectiveness within a community-based sample of adults with PTSD. This type of sample allows the study the opportunity to recruit both veteran and civilian subjects, two populations that can suffer from this clinical diagnosis and stand to benefit from this therapy. This study will:

  1. Evaluate the psychological effects of floating for a clinical, community sample with PTSD.
  2. Evaluate the physiological effects of floating for a clinical, community sample with PTSD.
  3. Evaluate the subjective effects of floating for a clinical, community sample with PTSD.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5
  • 18-60 years of age

Exclusion criteria

  • History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia)
  • Any skin conditions or open wounds that could cause pain when exposed to saltwater
  • Has floated previously
  • Has Schizophrenia spectrum or other psychotic disorders
  • Refuses to adhere to the Pre-Float Checklist
  • Non-English speaking
  • Inability to lay comfortably in a shallow pool of water
  • Refuses participation in the floatation-REST sessions
  • Refuses to sign the Float Liability Waiver prior to floating
  • No Communicable disease (e.g.- HIV, Hepatitis A, B& C, tuberculosis, or measles)
  • No psychoactive drugs or laxatives within the past week from scheduled float. Psychoactive drugs include, but are not limited to: methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), psilocybin, peyote, phencyclidine, ketamine).No recreational drug use (e.g.tetrahydrocannabinol,abuse of prescription medicine) day before or day of study visit. No antihistamine that causes drowsiness and no alcohol the day of the float sessions.
  • Lack of control of bodily functions prior to scheduled float
  • Fresh tattoos that would inhibit ability to float (consult with tattoo artist)
  • Colored/dyed hair less than one week old from scheduled float
  • Body tanning/spay/paint less than one week old from scheduled float
  • Active suicidal ideation

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Floating
Experimental group
Description:
Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.
Treatment:
Other: Floatation-based reduced environmental stimulation therapy

Trial contacts and locations

1

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Central trial contact

Kelley Jazinski-Chambers, BA; MCW Trauma Research Team

Data sourced from clinicaltrials.gov

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