About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First responder or other emergency medical personnel
Ability to read, speak and understand English
Capable of providing consent
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Floatation-REST
BehavioralParticipants 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.
Documentary
BehavioralParticipants will sit in a quiet room and watch a documentary.
Treatment groups
Trial outcomes
Primary outcomes
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.
Dropout Rate
As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/(# participants in specific arm).
Secondary outcomes
Burnout Effects of Floatation-REST
Burnout measured using the MBI-HSS questionnaire after each experimental session and at follow-up time points
Perceived Stress Effects of Floatation-REST
Perceived stress measured using the Perceived Stress Scale after each experimental session and at follow-up time points
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
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
Sponsors and contacts
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