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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368689
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Terri deRoon Cassini, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorders Other: Floatation-based reduced environmental stimulation therapy Not Applicable

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:

  1. Evaluate the psychological effects of floating for a clinical, community sample with PTSD.
  2. Evaluate the physiological effects of floating for a clinical, community sample with PTSD.
  3. Evaluate the subjective effects of floating for a clinical, community sample with PTSD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Floating
Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart.
Other: Floatation-based reduced environmental stimulation therapy
Completion of 3 float session that can last for up to 90 minutes each session, each spaced approximately one week apart




Primary Outcome Measures :
  1. Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: Baseline, week 2, week 3 ]
    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.

  2. Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by PTSD Checklist for DSM-5 [ Time Frame: Baseline, week 2, week 3 ]
    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.

  3. Change in depression symptom severity score as measured by the Center for Epidemiologic Studies Depression Scale - Revised [ Time Frame: Baseline, week 2, week 3 ]
    Center for Epidemiologic Studies Depression Scale - Revised Diagnostic tool for criteria for a major depressive episode

  4. Change in depressive symptom severity score as measured by Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, week 2, week 3 ]
    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.

  5. Change in stress symptom score [ Time Frame: Baseline, week 2, week 3 ]
    Perceived Stress Scale The Perceived Stress Scale is a psychological instrument used for measuring an individual's perception of stress.

  6. Change in Sheehan Disability Scale score [ Time Frame: Baseline, week 2, week 3 ]
    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.

  7. Change in perceived happiness score [ Time Frame: Baseline, week 2, week 3 ]
    Fordyce Happiness Measure Measures emotional well being by perceived happiness

  8. Change in anxiety symptom severity score [ Time Frame: Baseline, week 2, week 3 ]
    State-Trait Anxiety Inventory 20-item self-report questionnaire designed to assess an individual's level of anxiety.

  9. Change in Positive and Negative Affect [ Time Frame: Baseline, week 2, week 3 ]
    Positive and Negative Affect Schedule - Expanded Form 20-items survey assessing general states of positive and negative affect using on a 5 point scale

  10. Change in present moment sleepiness [ Time Frame: Baseline, week 2, week 3 ]
    Karolinska Sleepiness Scale Single item measure of present moment sleepiness

  11. Change in pain score [ Time Frame: Baseline, week 2, week 3 ]
    Wong-Baker Pain scale Rates current level of pain from 0 to 10.

  12. Change in Visual Analogue Scales score [ Time Frame: Baseline, week 2, week 3 ]
    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"

  13. Change in Side effect checklist score [ Time Frame: Baseline, week 2, week 3 ]
    Side effect checklist 43-item side effect checklist to assess the safety of Floatation- REST, and potential adverse experiences.

  14. Change in Skin Conductance response post float [ Time Frame: Baseline, Week 2, week 3 ]
    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.

  15. Change in blood pressure post float [ Time Frame: Baseline, Week 2, week 3 ]
    -Blood Pressure This will be measured using a blood pressure cuff. This is performed before and after each float.

  16. Change in number of mental health disorder diagnostic criteria met [ Time Frame: Baseline, Week 3 ]
    -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

  17. Anxiety sensitivity severity score pre float [ Time Frame: Baseline ]
    -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.

  18. Overall Anxiety Severity and Impairment score pre float [ Time Frame: Baseline ]
    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.

  19. Occurrence of adverse events post float [ Time Frame: Week 3 ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368689


Contacts
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Contact: Kelley Jazinski-Chambers, BA 414-955-1742 Kjazinski@mcw.edu
Contact: Amber Brandolino, MS 414-955-1728 abrandolino@mcw.edu

Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Terri deRoon-Cassini, PhD Medical College of Wisconsin
Publications:
Forgays, D. G., & Belinson, M. J. (1986). Is flotation isolation a relaxing environment?. Journal of Environmental Psychology, 6(1), 19-34.
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.
Lilly, J.C. & Shurley, J.T. (1961).
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.
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.
Shurley, J. T. (1960). Profound experimental sensory isolation. American Journal of Psychiatry, 117(6), 539-545.
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.

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Responsible Party: Terri deRoon Cassini, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04368689    
Other Study ID Numbers: PRO00032660
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terri deRoon Cassini, Medical College of Wisconsin:
Floatation-based Reduced Environmental Stimulation Therapy
PTSD
FLOAT
Trauma
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders