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Floating Therapy for PTSD (FLOAT Trial)

N/A
Recruiting
Led By Terri deRoon-Cassini, PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-60 years of age
Be between 18 and 65 years old
Must not have
Any skin conditions or open wounds that could cause pain when exposed to saltwater
Active suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if floating can help people with a history of trauma and stress-related symptoms.

Who is the study for?
This trial is for adults aged 18-60 with PTSD confirmed by the PCL-5. It's not for those with fresh tattoos, skin conditions, history of severe neurological issues, psychotic disorders, or who have floated before. Participants must be English-speaking and agree to a Pre-Float Checklist and Liability Waiver.
What is being tested?
The study tests floatation-based reduced environmental stimulation therapy on individuals with trauma-related stress symptoms. The aim is to see how 'floating' affects their condition.
What are the potential side effects?
Since this intervention involves a non-invasive relaxation technique in saltwater, side effects may include discomfort due to prolonged stillness or reactions to high salt concentration if there are open wounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have skin conditions or open wounds that saltwater could irritate.
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I am currently having thoughts about harming myself.
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I cannot control my bodily functions.
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I do not speak English.
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I cannot lay comfortably in a shallow pool of water.
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I have a history of serious neurological conditions.
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I do not want to participate in floatation-REST sessions.
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I do not have any communicable diseases like HIV or hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety sensitivity severity score pre float
Change in Positive and Negative Affect
Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FloatingExperimental Treatment1 Intervention
Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
631 Previous Clinical Trials
1,181,928 Total Patients Enrolled
Terri deRoon-Cassini, PhDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Floatation-based REST (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04368689 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Floating
Post-Traumatic Stress Disorder Clinical Trial 2023: Floatation-based REST Highlights & Side Effects. Trial Name: NCT04368689 — N/A
Floatation-based REST (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04368689 — N/A
~0 spots leftby Dec 2024
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