Clinical trial NCT04368689: The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD
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
Overall status: RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorders
Keywords: Floatation-based Reduced Environmental Stimulation Therapy
PTSD
FLOAT
Trauma
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline, week 2, week 3
measure: Change in Post Traumatic Stress Disorder (PTSD) symptom severity score as measured by PTSD Checklist for DSM-5
timeFrame: Baseline, week 2, week 3
measure: Change in depression symptom severity score as measured by the Center for Epidemiologic Studies Depression Scale - Revised
timeFrame: Baseline, week 2, week 3
measure: Change in depressive symptom severity score as measured by Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, week 2, week 3
measure: Change in stress symptom score
timeFrame: Baseline, week 2, week 3
measure: Change in Sheehan Disability Scale score
timeFrame: Baseline, week 2, week 3
measure: Change in perceived happiness score
timeFrame: Baseline, week 2, week 3
measure: Change in anxiety symptom severity score
timeFrame: Baseline, week 2, week 3
measure: Change in Positive and Negative Affect
timeFrame: Baseline, week 2, week 3
measure: Change in present moment sleepiness
timeFrame: Baseline, week 2, week 3
measure: Change in pain score
timeFrame: Baseline, week 2, week 3
measure: Change in Visual Analogue Scales score
timeFrame: Baseline, week 2, week 3
measure: Change in Side effect checklist score
timeFrame: Baseline, week 2, week 3
measure: Change in Skin Conductance response post float
timeFrame: Baseline, Week 2, week 3
measure: Change in blood pressure post float
timeFrame: Baseline, Week 2, week 3
measure: Change in number of mental health disorder diagnostic criteria met
timeFrame: Baseline, Week 3
measure: Anxiety sensitivity severity score pre float
timeFrame: Baseline
measure: Overall Anxiety Severity and Impairment score pre float
timeFrame: Baseline
measure: Occurrence of adverse events post float
timeFrame: Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Terri deRoon-Cassini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Forgays, D. G., & Belinson, M. J. (1986). Is flotation isolation a relaxing environment?. Journal of Environmental Psychology, 6(1), 19-34.
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.
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.
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.
citation: Lilly, J.C. & Shurley, J.T. (1961).
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.
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.
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.
citation: Shurley, J. T. (1960). Profound experimental sensory isolation. American Journal of Psychiatry, 117(6), 539-545.
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.