Active — Not RecruitingNot Applicable

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

United States30 participantsStarted 2021-06-18

Plain-language summary

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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Timeframe: Baseline, week 2, week 3

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by PTSD Checklist for DSM-5

Timeframe: Baseline, week 2, week 3

Change in depression symptom severity score as measured by the Center for Epidemiologic Studies Depression Scale - Revised

Timeframe: Baseline, week 2, week 3

Change in depressive symptom severity score as measured by Patient Health Questionnaire (PHQ-9)

Timeframe: Baseline, week 2, week 3

Change in stress symptom score

Timeframe: Baseline, week 2, week 3

Change in Sheehan Disability Scale score

Timeframe: Baseline, week 2, week 3

Change in perceived happiness score

Trial details

NCT IDNCT04368689

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Post-Traumatic Stress Disorders trials

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Timeframe: Baseline, week 2, week 3

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by PTSD Checklist for DSM-5

Timeframe: Baseline, week 2, week 3

Change in depression symptom severity score as measured by the Center for Epidemiologic Studies Depression Scale - Revised

Timeframe: Baseline, week 2, week 3

Change in depressive symptom severity score as measured by Patient Health Questionnaire (PHQ-9)

Timeframe: Baseline, week 2, week 3

Change in stress symptom score

Timeframe: Baseline, week 2, week 3

Change in Sheehan Disability Scale score

Timeframe: Baseline, week 2, week 3

Change in perceived happiness score