ACTIVE_NOT_RECRUITING

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

Conditions

Post-Traumatic Stress Disorders Floatation-based Reduced Environmental Stimulation Therapy PTSD FLOAT Trauma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

The Feasibility and Examination of the Effects of Floatation-based Reduced Environmental Stimulation Therapy (REST) on a Community Sample With Posttraumatic Stress Disorder (PTSD)

Quick Facts

Study Start:2021-06-18

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04368689

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.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5 * 18-60 years of age	* 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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Principal Investigator

Terri deRoon-Cassini, PhD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3548

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Terri deRoon-Cassini, PhD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

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 Registration Dates

Study Start Date2021-06-18

Study Completion Date2027-12

Study Record Updates

Study Start Date2021-06-18

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Floatation-based Reduced Environmental Stimulation Therapy
PTSD
FLOAT
Trauma

Additional Relevant MeSH Terms

Post-Traumatic Stress Disorders