Posttraumatic Stress SymptomsEarly Phase 1PTSS FLOATNCT07710417
FLOAT for Healthcare PTSS
A Early Phase 1 study testing Floatation-REST and Documentary in people with Posttraumatic Stress Symptoms and Burnout, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
This early-stage pilot trial aims to examine the feasibility, tolerability, and safety of Floatation-REST, or Reduced Environmental Stimulation Therapy via floatation in frontline healthcare workers, first responders, and emergency medical personnel who experience post-traumatic stress symptoms. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Posttraumatic Stress Symptoms, Burnout, Burnout, Healthcare Workers
- What is being tested?
- Floatation-REST and Documentary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Work-related post-traumatic stress dysfunction as measured by either of the following inclusion pathways:
- PTSS Pathway: PCL-5 greater than or equal to 20, OR meets criteria for full or partial PTSD on the MINI International Neuropsychiatric Interview 7 (DSM-V) (Criteria A + at least 2 B-E Criteria) OR (B) Functionally Anchored Pathway: evidence of work-related trauma exposure on the MINI International Neuropsychiatric Interview 7 (DSM-V) (Criterion A) or Life Events Checklist-5, and at least one of the following: Moral Injury and Distress Scale greater than or equal to 27, Sheehan Disability Scale greater than or equal to 5 on at least 1 of the 3 subscales, high or very high level of perceived stress (measured by PhenX Perceived Stress Scale greater than or equal to 16).
- First responder or other emergency medical personnel
- Ability to read, speak and understand English
- Capable of providing consent
Who cannot join
- History of neurological conditions
- Skin conditions or open wounds
- DSM-5 diagnosis of psychotic spectrum disorders, obsessive-compulsive disorder, bipolar disorder, severe substance use disorder, or eating disorder
- Inability to lay comfortably in a shallow pool of water
- Failure to adhere to "pre-float checklist"
- Breathalyzer test positive for alcohol or a drug-positive urine test
Show all 12Show fewer
- Unwillingness to provide consent or complete major aspects of protocol
- MRI contraindications
- Unstable medical diagnoses
- Pregnancy
- Evidence of inability to comply with study procedures based on experimenter judgement
- Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning (e.g., anxiolytics, antipsychotics, antidepressants, benzodiazepines, or mood stabilizers)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
LIBR Assessment Team, 918-502-5100, info@laureateinstitute.org
About this study
Official title: Neural Mechanisms of Floatation-REST Therapy for Post-Traumatic Stress Symptoms in Frontline Healthcare Workers
This early-stage pilot trial aims to examine the feasibility, tolerability, and safety of Floatation-REST, or Reduced Environmental Stimulation Therapy via floatation in frontline healthcare workers, first responders, and emergency medical personnel who experience post-traumatic stress symptoms.
Read the detailed description
Frontline healthcare workers, first responders, and emergency medical personnel are repeatedly exposed to occupational stressors and potentially traumatic events, placing them at elevated risk for post-traumatic stress symptoms (PTSS), burnout, anxiety, and related impairments. Current stress-reduction approaches for healthcare workers often have limited evidence for efficacy or may be difficult to implement in high-demand emergency and healthcare settings. Therefore, rapid, low-burden interventions that are feasible, tolerable, and safe for this population are needed.
Floatation-REST, or Reduced Environmental Stimulation Therapy, is a non-pharmacological intervention that reduces sensory input to the nervous system through the act of floating supine in a pool of warm water saturated with Epsom salt. The float environment is designed to reduce visual, auditory, thermal, tactile, vestibular, and proprioceptive stimulation. Prior studies suggest that Floatation-REST may acutely reduce stress and anxiety-related symptoms, but it has not yet been systematically evaluated in frontline healthcare workers with elevated PTSS.
This single-site, double-arm pilot study will examine the feasibility, tolerability, and safety of two 60-minute sessions of Floatation-REST compared with a documentary-viewing condition in adults ages 18 to 64 with work-related post-traumatic stress symptoms. Up to 30 participants will be recruited, with the goal of retaining 15 completers randomized on a 2:1 basis to Floatation-REST versus comparator condition. Participants will complete two in-person study visits at the Laureate Institute for Brain Research, including self-report questionnaires, blood and saliva collection, functional magnetic resonance imaging scans, and either Floatation-REST or documentary viewing. Follow-up surveys will be completed virtually up to one week after final intervention session.
The primary aim is to evaluate the safety and tolerability of Floatation-REST in this population. Secondary aims will explore whether Floatation-REST is associated with acute changes in PTSS, perceived stress, anxiety, burnout, mood, mindfulness, and moral injury-related distress. Exploratory aims will examine whether changes in brain network connectivity, salivary cortisol, and blood-based proteomic markers may help explain symptom change. Results from this early-stage study will help determine whether Floatation-REST should be further studied as a potential intervention for post-traumatic stress symptoms in frontline healthcare and emergency personnel.
- Conditions
- Posttraumatic Stress Symptoms, Burnout, Burnout, Healthcare Workers, First Responders, PTSD, Healthcare Workforce Well-Being
- Being tested
- Floatation-REST, Documentary
- Keywords
- Floatation-REST, Posttraumatic Stress Symptoms, PTSD, First Responders, Burnout, Healthcare Workers, Emergency Medical Personnel, Occupational Stress, Post-traumatic Stress Symptoms
- Medical subject headings
- Burnout, Psychological, Stress Disorders, Post-Traumatic, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floatation-RESTBehavioural
Participants float supine in a shallow pool of water saturated with Epsom salt. The environment is designed to minimize external stimulation via multiple channels including sound, light, and temperature.
DocumentaryBehavioural
Participants will sit in a quiet room and watch a documentary.
| Study group | Role | What they receive |
|---|---|---|
| Floatation-REST | Experimental | Participants will float supine in a shallow pool for two one-hour sessions approximately seven days apart. Receives: Behavioral: Floatation-REST |
| Documentary Condition | Active comparator | Participants will watch two one-hour documentaries in a relaxing environment approximately seven days apart. Receives: Behavioral: Documentary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects
Safety will be assessed using adverse events reported directly to study staff and adverse effects reported on the Floatation-REST effects checklist after each Floatation-REST or comparator session. As a proxy of safety, adverse effects will be calculated for each participant as the number of instances during the study in which the participant reports an increase above mild for any negatively experienced effect on the checklist.
Measured: From baseline to post-intervention seven day follow-up
Dropout Rate
As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/(# participants in specific arm).
Measured: Baseline through seven day post-intervention follow up
Secondary outcomes (4)
Burnout Effects of Floatation-REST
Burnout measured using the MBI-HSS questionnaire after each experimental session and at follow-up time points
Measured: Baseline through seven day post-intervention follow up
Perceived Stress Effects of Floatation-REST
Perceived stress measured using the Perceived Stress Scale after each experimental session and at follow-up time points
Measured: Baseline through seven day post-intervention follow up
Moral Injury Effects of Floatation-REST
Moral injury measured using the Moral Injury and Distress Scale after each experimental session and at follow-up time points
Measured: Baseline through seven day post-intervention follow up
Depressive Symptomatology Effects of Floatation-REST
Depressive symptoms measured using the Quick Inventory of Depressive Symptomatology (QIDS-SR) after each experimental session and at follow-up time points
Measured: Baseline through seven day post-intervention follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start10 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Early stage feasibility, tolerability, and safety pilot.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, adrienne taren, Laureate Institute for Brain Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710417
- Sponsor's protocol ID
- #20261153
- Acronym
- PTSS FLOAT
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Floatation-REST Therapy for Post-Traumatic Stress Symptoms in Frontline Healthcare Workers
- ClinicalTrials.gov ID
- NCT07710417
- Acronym / sponsor ID
- PTSS FLOAT / #20261153
- Conditions
- Posttraumatic Stress Symptoms, Burnout, Burnout, Healthcare Workers, First Responders, PTSD, Healthcare Workforce Well-Being
- Keywords
- Floatation-REST, Posttraumatic Stress Symptoms, PTSD, First Responders, Burnout, Healthcare Workers, Emergency Medical Personnel, Occupational Stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early-stage pilot trial aims to examine the feasibility, tolerability, and safety of Floatation-REST, or Reduced Environmental Stimulation Therapy via floatation in frontline healthcare workers, first responders, and emergency medical personnel who experience post-traumatic stress symptoms.
Detailed description
Frontline healthcare workers, first responders, and emergency medical personnel are repeatedly exposed to occupational stressors and potentially traumatic events, placing them at elevated risk for post-traumatic stress symptoms (PTSS), burnout, anxiety, and related impairments. Current stress-reduction approaches for healthcare workers often have limited evidence for efficacy or may be difficult to implement in high-demand emergency and healthcare settings. Therefore, rapid, low-burden interventions that are feasible, tolerable, and safe for this population are needed.
Floatation-REST, or Reduced Environmental Stimulation Therapy, is a non-pharmacological intervention that reduces sensory input to the nervous system through the act of floating supine in a pool of warm water saturated with Epsom salt. The float environment is designed to reduce visual, auditory, thermal, tactile, vestibular, and proprioceptive stimulation. Prior studies suggest that Floatation-REST may acutely reduce stress and anxiety-related symptoms, but it has not yet been systematically evaluated in frontline healthcare workers with elevated PTSS.
This single-site, double-arm pilot study will examine the feasibility, tolerability, and safety of two 60-minute sessions of Floatation-REST compared with a documentary-viewing condition in adults ages 18 to 64 with work-related post-traumatic stress symptoms. Up to 30 participants will be recruited, with the goal of retaining 15 completers randomized on a 2:1 basis to Floatation-REST versus comparator condition. Participants will complete two in-person study visits at the Laureate Institute for Brain Research, including self-report questionnaires, blood and saliva collection, functional magnetic resonance imaging scans, and either Floatation-REST or documentary viewing. Follow-up surveys will be completed virtually up to one week after final intervention session.
The primary aim is to evaluate the safety and tolerability of Floatation-REST in this population. Secondary aims will explore whether Floatation-REST is associated with acute changes in PTSS, perceived stress, anxiety, burnout, mood, mindfulness, and moral injury-related distress. Exploratory aims will examine whether changes in brain network connectivity, salivary cortisol, and blood-based proteomic markers may help explain symptom change. Results from this early-stage study will help determine whether Floatation-REST should be further studied as a potential intervention for post-traumatic stress symptoms in frontline healthcare and emergency personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Early stage feasibility, tolerability, and safety pilot.
| Arm | Type | Receives |
|---|---|---|
| Floatation-REST | Experimental | Behavioral: Floatation-RESTParticipants will float supine in a shallow pool for two one-hour sessions approximately seven days apart. |
| Documentary Condition | Active comparator | Behavioral: DocumentaryParticipants will watch two one-hour documentaries in a relaxing environment approximately seven days apart. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Work-related post-traumatic stress dysfunction as measured by either of the following inclusion pathways:
- First responder or other emergency medical personnel
- Ability to read, speak and understand English
- Capable of providing consent
Key exclusion criteria (12 listed)
- History of neurological conditions
- Skin conditions or open wounds
- DSM-5 diagnosis of psychotic spectrum disorders, obsessive-compulsive disorder, bipolar disorder, severe substance use disorder, or eating disorder
- Inability to lay comfortably in a shallow pool of water
- Failure to adhere to "pre-float checklist"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floatation-RESTParticipants float supine in a shallow pool of water saturated with Epsom salt. The environment is designed to minimize external stimulation via multiple channels including sound, light, and temperature. | Behavioural | Floatation-REST |
| DocumentaryParticipants will sit in a quiet room and watch a documentary. | Behavioural | Documentary Condition |
Primary outcome
Adverse effects
Time frame: From baseline to post-intervention seven day follow-up
Safety will be assessed using adverse events reported directly to study staff and adverse effects reported on the Floatation-REST effects checklist after each Floatation-REST or comparator session. As a proxy of safety, adverse effects will be calculated for each participant as the number of instances during the study in which the participant reports an increase above mild for any negatively experienced effect on the checklist.
Dropout Rate
Time frame: Baseline through seven day post-intervention follow up
As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/(# participants in specific arm).
4 secondary outcomes
Burnout Effects of Floatation-REST
Time frame: Baseline through seven day post-intervention follow up
Perceived Stress Effects of Floatation-REST
Time frame: Baseline through seven day post-intervention follow up
Moral Injury Effects of Floatation-REST
Time frame: Baseline through seven day post-intervention follow up
Depressive Symptomatology Effects of Floatation-REST
Time frame: Baseline through seven day post-intervention follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Floatation-REST and Documentary in people with Posttraumatic Stress Symptoms and Burnout, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrienne Taren, MD, PhD (918-340-4116, ataren@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects (time frame: From baseline to post-intervention seven day follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.