FLOAT for Healthcare PTSS

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorLaureate Institute for Brain Research, Inc.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Floatation-REST

    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.

  • Documentary

    Behavioral

    Participants will sit in a quiet room and watch a documentary.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Floatation-RESTExperimental treatment 1 intervention
Group B: Documentary ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline to post-intervention seven day follow-up
2

Dropout Rate

As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/(# participants in specific arm).

Time frame
Baseline through seven day post-intervention follow up

Secondary outcomes

1

Burnout Effects of Floatation-REST

Burnout measured using the MBI-HSS questionnaire after each experimental session and at follow-up time points

Time frame
Baseline through seven day post-intervention follow up
2

Perceived Stress Effects of Floatation-REST

Perceived stress measured using the Perceived Stress Scale after each experimental session and at follow-up time points

Time frame
Baseline through seven day post-intervention follow up
3

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

Time frame
Baseline through seven day post-intervention follow up
4

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

Time frame
Baseline through seven day post-intervention follow up

Other outcomes

Sponsors and contacts

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