[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07710417":3,"trial-entities:NCT07710417":107,"trial-summary:NCT07710417":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":48,"secondary_outcomes":57,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":77,"locations":79,"central_contacts":95,"overall_officials":104,"references":105,"see_also_links":106},"NCT07710417","#20261153","FLOAT for Healthcare PTSS","Neural Mechanisms of Floatation-REST Therapy for Post-Traumatic Stress Symptoms in Frontline Healthcare Workers","RECRUITING","2026-12","2026-07","2026-07-17","2026-06-10","Laureate Institute for Brain Research, Inc.","OTHER",false,"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.","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.\n\nFloatation-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.\n\nThis 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.\n\nThe 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.",[19,20,21,22,23,24,25],"Posttraumatic Stress Symptoms","Burnout","Burnout, Healthcare Workers","First Responders","PTSD","Healthcare Workforce Well-Being","Post-traumatic Stress Symptoms",[27,19,23,22,20,28,29,30,25],"Floatation-REST","Healthcare Workers","Emergency Medical Personnel","Occupational Stress","INTERVENTIONAL","TREATMENT",[34],"EARLY_PHASE1",{"count":36,"type":37},15,"ESTIMATED",[39,43],{"type":40,"name":27,"description":41,"armGroupLabels":42},"BEHAVIORAL","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.",[27],{"type":40,"name":44,"description":45,"armGroupLabels":46},"Documentary","Participants will sit in a quiet room and watch a documentary.",[47],"Documentary Condition",[49,53],{"measure":50,"description":51,"timeFrame":52},"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.","From baseline to post-intervention seven day follow-up",{"measure":54,"description":55,"timeFrame":56},"Dropout Rate","As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)\u002F(# participants in specific arm).","Baseline through seven day post-intervention follow up",[58,61,64,67],{"measure":59,"description":60,"timeFrame":56},"Burnout Effects of Floatation-REST","Burnout measured using the MBI-HSS questionnaire after each experimental session and at follow-up time points",{"measure":62,"description":63,"timeFrame":56},"Perceived Stress Effects of Floatation-REST","Perceived stress measured using the Perceived Stress Scale after each experimental session and at follow-up time points",{"measure":65,"description":66,"timeFrame":56},"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",{"measure":68,"description":69,"timeFrame":56},"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","ALL","18 Years","64 Years",{"inclusion":74,"exclusion":75,"raw_text":76},[],[],"Inclusion Criteria:\n\n1. Work-related post-traumatic stress dysfunction as measured by either of the following inclusion pathways:\n\n   (A) 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).\n2. First responder or other emergency medical personnel\n3. Ability to read, speak and understand English\n4. Capable of providing consent\n\nExclusion Criteria:\n\n1. History of neurological conditions\n2. Skin conditions or open wounds\n3. DSM-5 diagnosis of psychotic spectrum disorders, obsessive-compulsive disorder, bipolar disorder, severe substance use disorder, or eating disorder\n4. Inability to lay comfortably in a shallow pool of water\n5. Failure to adhere to \"pre-float checklist\"\n6. Breathalyzer test positive for alcohol or a drug-positive urine test\n7. Unwillingness to provide consent or complete major aspects of protocol\n8. MRI contraindications\n9. Unstable medical diagnoses\n10. Pregnancy\n11. Evidence of inability to comply with study procedures based on experimenter judgement\n12. 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)",[78],"ADULT",[80],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":92},"Laureate Institute for Brain Research","Tulsa","Oklahoma","74136","United States",[87],{"name":88,"role":89,"phone":90,"email":91},"LIBR Assessment Team","CONTACT","918-502-5100","info@laureateinstitute.org",{"lat":93,"lon":94},36.15398,-95.99277,[96,100],{"name":97,"role":89,"phone":98,"email":99},"Adrienne Taren, MD, PhD","918-340-4116","ataren@laureateinstitute.org",{"name":101,"role":89,"phone":102,"email":103},"Emily M Choquette, PhD","918-240-2583","echoquette@laureateinstitute.org",[],[],[],{"nct_id":4,"conditions":108,"biomarkers":111},[109,110],"Physical AND emotional exhaustion state","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an early-stage pilot study that will compare two groups: one receiving Floatation-REST and another watching a documentary. About 15 participants will be included.","completed","FLOAT for Healthcare PTSS: Floatation-REST for Post-Traumatic Stress Symptoms","This early-stage study is looking at a treatment called Floatation-REST for healthcare workers and first responders who have post-traumatic stress symptoms (PTSS) or burnout. Floatation-REST involves floating in a shallow pool of water with Epsom salt, in a quiet environment designed to reduce outside stimulation. The study wants to see if this treatment is practical, well-tolerated, and safe. You might be able to join if you are between 18 and 64 years old and have work-related PTSS. The study will compare Floatation-REST to watching a documentary. This study is currently recruiting about 15 participants.","Adverse effects and dropout rates will be tracked from the start of the study until seven days after the intervention.",94,"Participants will have two 60-minute sessions of either Floatation-REST or watching a documentary.","Not stated in the trial record.",[27,44],"v2"]