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The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD (FLOAT)

Primary Purpose

Post-Traumatic Stress Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Floatation-based reduced environmental stimulation therapy

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorders focused on measuring Floatation-based Reduced Environmental Stimulation Therapy, PTSD, FLOAT, Trauma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5
18-60 years of age

Exclusion Criteria:

History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia)
Any skin conditions or open wounds that could cause pain when exposed to saltwater
Has floated previously
Has Schizophrenia spectrum or other psychotic disorders
Refuses to adhere to the Pre-Float Checklist
Non-English speaking
Inability to lay comfortably in a shallow pool of water
Refuses participation in the floatation-REST sessions
Refuses to sign the Float Liability Waiver prior to floating
No Communicable disease (e.g.- HIV, Hepatitis A, B& C, tuberculosis, or measles)
No psychoactive drugs or laxatives within the past week from scheduled float. Psychoactive drugs include, but are not limited to: methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), psilocybin, peyote, phencyclidine, ketamine).No recreational drug use (e.g.tetrahydrocannabinol,abuse of prescription medicine) day before or day of study visit. No antihistamine that causes drowsiness and no alcohol the day of the float sessions.
Lack of control of bodily functions prior to scheduled float
Fresh tattoos that would inhibit ability to float (consult with tattoo artist)
Colored/dyed hair less than one week old from scheduled float
Body tanning/spay/paint less than one week old from scheduled float
Active suicidal ideation

Sites / Locations

Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Floating

Arm Description

Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.

Outcomes

Primary Outcome Measures

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.

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.

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

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.

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.

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.

Change in perceived happiness score

Fordyce Happiness Measure Measures emotional well being by perceived happiness

Change in anxiety symptom severity score

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

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

Change in present moment sleepiness

Karolinska Sleepiness Scale Single item measure of present moment sleepiness

Change in pain score

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

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"

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.

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.

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.

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

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.

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04368689

First Posted

April 1, 2020

Last Updated

May 8, 2023

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT04368689

Brief Title

The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD

Acronym

FLOAT

Official Title

The Feasibility and Examination of the Effects of Floatation-based Reduced Environmental Stimulation Therapy (REST) on a Community Sample With Posttraumatic Stress Disorder (PTSD)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 18, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms.

Detailed Description

This pilot study looks to further the current floatation-based REST literature by exploring the therapy's effectiveness within a community-based sample of adults with PTSD. This type of sample allows the study the opportunity to recruit both veteran and civilian subjects, two populations that can suffer from this clinical diagnosis and stand to benefit from this therapy. This study will: Evaluate the psychological effects of floating for a clinical, community sample with PTSD. Evaluate the physiological effects of floating for a clinical, community sample with PTSD. Evaluate the subjective effects of floating for a clinical, community sample with PTSD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorders

Keywords

Floatation-based Reduced Environmental Stimulation Therapy, PTSD, FLOAT, Trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Floating

Arm Type

Experimental

Arm Description

Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.

Intervention Type

Other

Intervention Name(s)

Floatation-based reduced environmental stimulation therapy

Intervention Description

Completion of 3 float session that can last for up to 90 minutes each session, each spaced approximately one week apart

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline, week 2, week 3

Title

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

Description

Time Frame

Baseline, week 2, week 3

Title

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

Description

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

Time Frame

Baseline, week 2, week 3

Title

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

Description

Time Frame

Baseline, week 2, week 3

Title

Change in stress symptom score

Description

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

Time Frame

Baseline, week 2, week 3

Title

Change in Sheehan Disability Scale score

Description

Time Frame

Baseline, week 2, week 3

Title

Change in perceived happiness score

Description

Fordyce Happiness Measure Measures emotional well being by perceived happiness

Time Frame

Baseline, week 2, week 3

Title

Change in anxiety symptom severity score

Description

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

Time Frame

Baseline, week 2, week 3

Title

Change in Positive and Negative Affect

Description

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

Time Frame

Baseline, week 2, week 3

Title

Change in present moment sleepiness

Description

Karolinska Sleepiness Scale Single item measure of present moment sleepiness

Time Frame

Baseline, week 2, week 3

Title

Change in pain score

Description

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

Time Frame

Baseline, week 2, week 3

Title

Change in Visual Analogue Scales score

Description

Time Frame

Baseline, week 2, week 3

Title

Change in Side effect checklist score

Description

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

Time Frame

Baseline, week 2, week 3

Title

Change in Skin Conductance response post float

Description

Time Frame

Baseline, Week 2, week 3

Title

Change in blood pressure post float

Description

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

Time Frame

Baseline, Week 2, week 3

Title

Change in number of mental health disorder diagnostic criteria met

Description

Time Frame

Baseline, Week 3

Title

Anxiety sensitivity severity score pre float

Description

Time Frame

Baseline

Title

Overall Anxiety Severity and Impairment score pre float

Description

Time Frame

Baseline

Title

Occurrence of adverse events post float

Description

Time Frame

Week 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5 18-60 years of age Exclusion Criteria: History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia) Any skin conditions or open wounds that could cause pain when exposed to saltwater Has floated previously Has Schizophrenia spectrum or other psychotic disorders Refuses to adhere to the Pre-Float Checklist Non-English speaking Inability to lay comfortably in a shallow pool of water Refuses participation in the floatation-REST sessions Refuses to sign the Float Liability Waiver prior to floating No Communicable disease (e.g.- HIV, Hepatitis A, B& C, tuberculosis, or measles) No psychoactive drugs or laxatives within the past week from scheduled float. Psychoactive drugs include, but are not limited to: methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), psilocybin, peyote, phencyclidine, ketamine).No recreational drug use (e.g.tetrahydrocannabinol,abuse of prescription medicine) day before or day of study visit. No antihistamine that causes drowsiness and no alcohol the day of the float sessions. Lack of control of bodily functions prior to scheduled float Fresh tattoos that would inhibit ability to float (consult with tattoo artist) Colored/dyed hair less than one week old from scheduled float Body tanning/spay/paint less than one week old from scheduled float Active suicidal ideation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kelley Jazinski-Chambers, BA

Phone

414-955-1742

Kjazinski@mcw.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Isela Pina, MS

Phone

414-510-9895

ipina@mcw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terri deRoon-Cassini, PhD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226-3548

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Terri deRoon-Cassini, PhD

Phone

414-955-1742

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29394251

Citation

Feinstein JS, Khalsa SS, Yeh HW, Wohlrab C, Simmons WK, Stein MB, Paulus MP. Examining the short-term anxiolytic and antidepressant effect of Floatation-REST. PLoS One. 2018 Feb 2;13(2):e0190292. doi: 10.1371/journal.pone.0190292. eCollection 2018.

Results Reference

background

PubMed Identifier

29656950

Citation

Feinstein JS, Khalsa SS, Yeh H, Al Zoubi O, Arevian AC, Wohlrab C, Pantino MK, Cartmell LJ, Simmons WK, Stein MB, Paulus MP. The Elicitation of Relaxation and Interoceptive Awareness Using Floatation Therapy in Individuals With High Anxiety Sensitivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):555-562. doi: 10.1016/j.bpsc.2018.02.005. Epub 2018 Mar 9.

Results Reference

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PubMed Identifier

7159352

Citation

Fine TH, Turner JW Jr. The effect of brief restricted environmental stimulation therapy in the treatment of essential hypertension. Behav Res Ther. 1982;20(6):567-70. doi: 10.1016/0005-7967(82)90035-3. No abstract available.

Results Reference

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Citation

Forgays, D. G., & Belinson, M. J. (1986). Is flotation isolation a relaxing environment?. Journal of Environmental Psychology, 6(1), 19-34.

Results Reference

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PubMed Identifier

6399246

Citation

Jacobs GD, Heilbronner RL, Stanley JM. The effects of short term flotation REST on relaxation: a controlled study. Health Psychol. 1984;3(2):99-112. doi: 10.1037//0278-6133.3.2.99.

Results Reference

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PubMed Identifier

11854763

Citation

Kjellgren A, Sundequist U, Norlander T, Archer T. Effects of flotation-REST on muscle tension pain. Pain Res Manag. 2001 Winter;6(4):181-9. doi: 10.1155/2001/768501.

Results Reference

background

Citation

Koula, G. M., Kemp, J. C., Keane, K. M., & Belden, A. D. (1990). Replication of a clinical outcome study on a hospital-based stress management and behavioral medicine program utilizing flotation REST and biofeedback. In Restricted Environmental Stimulation (pp. 202-209). Springer, New York.

Results Reference

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Citation

Lilly, J.C. & Shurley, J.T. (1961).

Results Reference

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Citation

O'Leary, D. S., & Heilbronner, R. L. (1990). Flotation REST and information processing: A reaction time study. In Restricted Environmental Stimulation (pp. 113-124). Springer New York.

Results Reference

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Citation

Pudvah, M. B., & Rzewnicki, R. (1990). Six months in the tank: Long-term effects of flotation isolation on state anxiety, hostility, and depression. Restricted Environmental Stimulation: Theoretical and empirical developments in flotation REST, 169-173.

Results Reference

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PubMed Identifier

8003591

Citation

Schulz P, Kaspar CH. Neuroendocrine and psychological effects of restricted environmental stimulation technique in a flotation tank. Biol Psychol. 1994 Mar;37(2):161-75. doi: 10.1016/0301-0511(94)90029-9.

Results Reference

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Citation

Shurley, J. T. (1960). Profound experimental sensory isolation. American Journal of Psychiatry, 117(6), 539-545.

Results Reference

background

Citation

Turner Jr, J., Gerard, W., Hyland, J., Nieland, P., & Fine, T. (1993). Effects of wet and dry flotation REST on blood pressure and plasma cortisol. In Clinical and Experimental Restricted Environmental Stimulation (pp. 239-247). Springer New York.

Results Reference

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The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD

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