Clinical Trial Radar

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) A clinician-administered structured diagnostic interview that is considered the gold standard for assessing and diagnosing PTSD.

Baseline, week 2, week 3

Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by PTSD Checklist for DSM-5

PTSD Checklist for DSM-5 The PCL-5 consists of 20 items and it takes 5 to 10 minutes to administer. Participants are instructed to answer items based on their experience of symptoms since the trauma (hospitalization) or in the last month (1 month). Each item corresponds to a symptom in the DSM-5.

Baseline, week 2, week 3

Change in depression symptom severity score as measured by the Center for Epidemiologic Studies Depression Scale - Revised

Center for Epidemiologic Studies Depression Scale - Revised Diagnostic tool for criteria for a major depressive episode

Baseline, week 2, week 3

Change in depressive symptom severity score as measured by Patient Health Questionnaire (PHQ-9)

Patient Health Questionnaire (PHQ-9) The PHQ-9 is a 9-Item measure for assessing the severity of depressive symptoms over the past 2 weeks. Scores of 1-4 are considered indicative of minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.

Baseline, week 2, week 3

Change in stress symptom score

Perceived Stress Scale The Perceived Stress Scale is a psychological instrument used for measuring an individual's perception of stress.

Baseline, week 2, week 3

Change in Sheehan Disability Scale score

Sheehan Disability Scale How much mental health issues have affected their daily activities: work/school, social/leisure activities, and family life/home responsibilities. Total disability scores range between 0 to 30, with scores ≥ 5 signifying impairment.

Baseline, week 2, week 3

Change in perceived happiness score

Fordyce Happiness Measure Measures emotional well being by perceived happiness

Baseline, week 2, week 3

Change in anxiety symptom severity score

State-Trait Anxiety Inventory 20-item self-report questionnaire designed to assess an individual's level of anxiety.

Baseline, week 2, week 3

Change in Positive and Negative Affect

Positive and Negative Affect Schedule - Expanded Form 20-items survey assessing general states of positive and negative affect using on a 5 point scale

Baseline, week 2, week 3

Change in present moment sleepiness

Karolinska Sleepiness Scale Single item measure of present moment sleepiness

Baseline, week 2, week 3

Change in pain score

Wong-Baker Pain scale Rates current level of pain from 0 to 10.

Baseline, week 2, week 3

Change in Visual Analogue Scales score

Visual Analogue Scales- Relaxation, Muscle tension, Content/Peaceful, Refreshed, Energy \& Overall Well-Being 7 measures rating on a 100-point scale and assessing overall well-being using a bipolar valence scale that goes from "Pretty Bad" to "Pretty Good"

Baseline, week 2, week 3

Change in Side effect checklist score

Side effect checklist 43-item side effect checklist to assess the safety of Floatation- REST, and potential adverse experiences.

Baseline, week 2, week 3

Change in Skin Conductance response post float

Skin Conductance This will be measured using a program called "eSense". eSense (Mindfield Biosystems LLC), an ambulatory system for collecting skin conductance, or sweat gland activity. eSense samples skin conductance at 5 Hz, substantially lower than more traditional (and more expensive) laboratory systems. This will be done during the Trauma Narrative where subjects are asked to describe an event that they consider to be the most traumatic in their life including: who was there, what they were doing, where they were, how things looked, what they heard, etc.

Baseline, Week 2, week 3

Change in blood pressure post float

-Blood Pressure This will be measured using a blood pressure cuff. This is performed before and after each float.

Baseline, Week 2, week 3

Change in number of mental health disorder diagnostic criteria met

-Mini International Neuropsychiatric Interview - Depression (M.I.N.I. 7.0.2) The MINI is a short structured diagnostic interview designed to meet the need for a short but accurate psychiatric interview determining diagnostic criteria for 17 of the most common disorders in mental health. This version is for DSM-5 and ICD-10 diagnoses. The measure's psychometric properties of diagnostic validity and reliability have been determined to be strong

Baseline, Week 3

Anxiety sensitivity severity score pre float

-Anxiety Sensitivity Index (ASI-3) 18-item questionnaire using a 4-point scale and total ASI scores can range from 0 to 72. A meta-analysis \[46\] found that patient groups with anxiety and depression commonly have a total ASI score above 30, and other studies have used a cutoff score ≥ 30 to recruit individuals with very high levels of anxiety sensitivity.

Baseline

Overall Anxiety Severity and Impairment score pre float

Overall Anxiety Severity and Impairment Scale A 5-item questionnaire that can be used across the different anxiety disorders as a continuous measure of anxiety severity and impairment over the past week. Each item is rated on a 5-point scale and the ratings are summed to obtain a total score ranging from 0 to 20.

Baseline

Occurrence of adverse events post float

Debriefing Interview Occurrence of adverse events and qualitative information about floating. How was your float today? What did you think about while floating? Did anything surprise you? Did you learn anything about yourself? Follow-up Questions At the end of your float, how did you feel about the duration? Wanted to get out before/Perfect amount of time/Wish I could have stayed longer. Other techniques tried to help relax and feel less anxious and stressed? anti-anxiety medication/psychotherapy/massage/exercise/alcohol/breathing techniques/cigarettes/marijuana/progressive muscle relaxation/meditation/yoga/other Experience during and after today's float session compared to the other relaxation techniques tired? More relaxation with others/Equally as good as the others/More relaxation with floating than any others Interested in floating again in the future and thoughts on specialized pools being effective therapy for reducing symptom severity? Yes/No/Maybe

Week 3