Floating Therapy for PTSD

(FLOAT Trial)

Overseen By MCW Trauma Research Team

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Psychoactive drugs, Laxatives

Disqualifiers: Neurological conditions, Schizophrenia, Communicable disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how floatation therapy (also known as Floatation-based REST) can help people with PTSD (posttraumatic stress disorder) manage stress-related symptoms. Participants will undergo three floating sessions, each lasting up to 90 minutes and spaced about a week apart. The trial seeks individuals diagnosed with PTSD who have never tried floating and have no history of neurological conditions or recent skin issues. As an unphased trial, this study offers a unique opportunity to explore a novel approach to managing PTSD symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use psychoactive drugs or laxatives within a week before the float, and you should avoid recreational drugs, certain antihistamines, and alcohol the day of the float.

What prior data suggests that Floatation-based REST is safe for individuals with PTSD?

Research has shown that floatation-based REST is generally safe for most people. One study found that six sessions of this therapy were well-tolerated and safe for individuals with anxiety and depression, with no significant negative effects reported.

Another review suggests that floatation-REST can help reduce anxiety, improve sleep, and ease chronic pain. These benefits highlight the therapy's positive impact on mental health and physical comfort.

Overall, studies consider floatation-based REST safe and manageable for most people. Prospective trial participants may find this information reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Floating therapy is unique because it offers a non-invasive, drug-free approach to managing PTSD symptoms. Unlike standard treatments like psychotherapy or medications such as SSRIs and SNRIs, floating therapy involves sensory deprivation through floatation-based REST (Restricted Environmental Stimulation Therapy). This method creates a deeply relaxing environment that can help reduce stress and anxiety, potentially leading to quicker symptom relief. Researchers are excited because this approach may offer an alternative for those who prefer or need to avoid medication, providing a new pathway to healing that focuses on relaxation and mental reset.

What evidence suggests that Floatation-based REST is effective for PTSD?

Research has shown that Floatation-based REST (Restricted Environmental Stimulus Therapy), which participants in this trial will experience, can reduce anxiety and improve mental well-being. Studies indicate it can also ease chronic pain, improve sleep, and enhance creativity and thinking skills. In trials, people with anxiety and depression found floatation safe and manageable. Although limited data exists specifically for PTSD, its calming effects on the nervous system make it a promising option for stress-related symptoms. This therapy offers a unique way to relax by providing a peaceful, stress-free environment for the mind and body. ^{1 2 3 4 5}

Who Is on the Research Team?

Terri deRoon-Cassini, PhD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5

Exclusion Criteria

I have skin conditions or open wounds that saltwater could irritate.

Fresh tattoos that would inhibit ability to float (consult with tattoo artist)

I am currently having thoughts about harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants have 3 Floatation sessions that last up to 90 minutes each, spaced about a week apart

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD symptom severity and other psychological and physiological measures

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Floatation-based REST

Trial Overview 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.

How Is the Trial Designed?

Group I: Floating Experimental Treatment 1 Intervention

Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.

Floatation-based REST is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Flotation-REST for:

• Anxiety
• Depression
• PTSD

Approved in Canada as Flotation-REST for:

• Anxiety
• Depression
• PTSD

Approved in European Union as Flotation-REST for:

• Anxiety
• Depression
• PTSD

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

The article reviews common causes and symptoms of Post-Traumatic Stress Disorder (PTSD), focusing on combat-related trauma in Vietnam veterans, highlighting the need for targeted treatment approaches.

It proposes a series of graded treatment activities designed to help individuals process and release negative emotions associated with trauma, ultimately aiming to facilitate healing and a positive transition to healthier living.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activities for the treatment of combat-related post-traumatic stress disorder. Short-Degraff, MA., Engelmann, T.[2013]

Cognitive-behavioral therapy (CBT) is the most supported treatment for posttraumatic stress disorder (PTSD), encompassing both specific manualized approaches and more flexible applications.

The review analyzed 14 studies published between 2009 and 2012 to identify trends and potential enhancements in CBT for PTSD, indicating a growing interest in optimizing these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatments for posttraumatic stress disorder: empirical foundation and new directions. Koucky, EM., Dickstein, BD., Chard, KM.[2018]

Virtual reality exposure therapy (VRET) has been shown to be more effective than waitlist control groups in treating PTSD, with a significant effect size indicating its potential as a treatment option.

However, VRET's efficacy compared to other active treatments was not significantly different, highlighting the need for more high-quality studies to better understand its effectiveness and safety, especially since most existing studies had low quality and varied methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of immersive PTSD treatments: A systematic review of virtual and augmented reality exposure therapy and a meta-analysis of virtual reality exposure therapy. Eshuis, LV., van Gelderen, MJ., van Zuiden, M., et al.[2021]

In a study of 110 patients with chronic PTSD, 43 acute responders were followed up after 3 months, showing that most maintained their treatment gains, particularly those who received interpersonal psychotherapy (IPT), with 100% of IPT patients remaining in remission.

Prolonged exposure therapy (PE) demonstrated the best long-term outcomes, with a low relapse rate of 7%, while relaxation therapy (RT) had the highest relapse rate at 33%, indicating that PE may be the most effective option for sustained improvement in PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Acute Benefits of Interpersonal Psychotherapy for Posttraumatic Stress Disorder Endure? Markowitz, JC., Choo, TH., Neria, Y.[2019]

The study evaluated a 5-week therapist-guided internet-based cognitive-behavioral therapy (iCBT) for 37 service members with PTSD, but found that improvements in PTSD symptoms were small and not statistically significant.

While there were small significant improvements in anxiety levels from pre-treatment to follow-up, the high dropout rate of 32.3% highlights challenges in treatment engagement among military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an internet-based intervention for service members of the German armed forces with deployment-related posttraumatic stress symptoms. Niemeyer, H., Knaevelsrud, C., Schumacher, S., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12224670/

A systematic review of flotation-restricted environmental ... Research suggests that REST can help reduce anxiety, alleviate chronic pain, improve sleep, and enhance creativity and cognitive function.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04368689

The Feasibility and Examination of the Effects of Floatation ... This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms. Detailed Description.

3. medrxiv.org medrxiv.org/content/10.1101/2023.11.29.23299203v1.full

A systematic review of Flotation-Restricted Environmental ... Research suggests that REST can help reduce anxiety, alleviate chronic pain, improve sleep, and enhance creativity and cognitive function.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0286899

A randomized controlled safety and feasibility trial of floatation ... Six sessions of floatation-REST appear feasible, well-tolerated, and safe in anxious and depressed individuals.

5. worksafebc.com worksafebc.com/resources/health-care-providers/guides/restricted-environmental-stimulus-therapy-treatment-post-traumatic-stress-disorder-2024-update?lang=en&direct

Restricted Environmental Stimulus Therapy (REST) as ... To determine whether there is any evidence to support the efficacy and/or effectiveness of using restricted environmental stimulus therapy (REST) ...