Post-Traumatic Stress DisordersFLOATNCT04368689
The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD
A study testing Floatation-based reduced environmental stimulation therapy in people with Post-Traumatic Stress Disorders, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Traumatic Stress Disorders
- What is being tested?
- Floatation-based reduced environmental stimulation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5
- 18-60 years of age
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3548
About this study
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)
This project is being done to explore the effects floating has on individuals who have a history of trauma with stress related symptoms.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorders
- Being tested
- Floatation-based reduced environmental stimulation therapy
- Keywords
- Floatation-based Reduced Environmental Stimulation Therapy, PTSD, FLOAT, Trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floatation-based reduced environmental stimulation therapyOther
Completion of 3 float session that can last for up to 90 minutes each session, each spaced approximately one week apart
| Study group | Role | What they receive |
|---|---|---|
| Floating | Experimental | Participants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart. Receives: Other: Floatation-based reduced environmental stimulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 2, week 3
Change in perceived happiness score
Fordyce Happiness Measure Measures emotional well being by perceived happiness
Measured: 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.
Measured: 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
Measured: Baseline, week 2, week 3
Change in present moment sleepiness
Karolinska Sleepiness Scale Single item measure of present moment sleepiness
Measured: Baseline, week 2, week 3
Change in pain score
Wong-Baker Pain scale Rates current level of pain from 0 to 10.
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start18 Jun 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisordersStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terri deRoon Cassini, Medical College of Wisconsin
- Investigators
- Terri deRoon-Cassini, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368689
- Sponsor's protocol ID
- PRO00032660
- Acronym
- FLOAT
- Status last verified
- Jan 2026
- First submitted
- 1 Apr 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29394251Feinstein 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.
PubMed 29656950Fine 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.
PubMed 7159352Forgays, D. G., & Belinson, M. J. (1986). Is flotation isolation a relaxing environment?. Journal of Environmental Psychology, 6(1), 19-34.
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.
PubMed 6399246Kjellgren 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.
PubMed 11854763Koula, 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.
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.
PubMed 8003591Shurley, 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04368689
- Acronym / sponsor ID
- FLOAT / PRO00032660
- Conditions
- Post-Traumatic Stress Disorders
- Keywords
- Floatation-based Reduced Environmental Stimulation Therapy, PTSD, FLOAT, Trauma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Floating | Experimental | Other: Floatation-based reduced environmental stimulation therapyParticipants have 3 Floatation sessions that last up to 90 minutes. Each spaced about a week apart. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has posttraumatic stress disorder (PTSD) as confirmed by the PCL-5
- 18-60 years of age
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floatation-based reduced environmental stimulation therapyCompletion of 3 float session that can last for up to 90 minutes each session, each spaced approximately one week apart | Other | Floating |
Primary outcome
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.
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.
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
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.
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.
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.
Change in perceived happiness score
Time frame: Baseline, week 2, week 3
Fordyce Happiness Measure Measures emotional well being by perceived happiness
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.
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
Change in present moment sleepiness
Time frame: Baseline, week 2, week 3
Karolinska Sleepiness Scale Single item measure of present moment sleepiness
Change in pain score
Time frame: Baseline, week 2, week 3
Wong-Baker Pain scale Rates current level of pain from 0 to 10.
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"
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.
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.
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.
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
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 29394251Feinstein 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.
- Background: PubMed 29656950Feinstein 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.
- Background: PubMed 7159352Fine 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.
- BackgroundForgays, D. G., & Belinson, M. J. (1986). Is flotation isolation a relaxing environment?. Journal of Environmental Psychology, 6(1), 19-34.
- Background: PubMed 6399246Jacobs 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.
- Background: PubMed 11854763Kjellgren 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.
- BackgroundKoula, 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.
- BackgroundLilly, J.C. & Shurley, J.T. (1961).
- BackgroundO'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.
- BackgroundPudvah, 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.
- Background: PubMed 8003591Schulz 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.
- BackgroundShurley, J. T. (1960). Profound experimental sensory isolation. American Journal of Psychiatry, 117(6), 539-545.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terri deRoon-Cassini, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floatation-based reduced environmental stimulation therapy in people with Post-Traumatic Stress Disorders, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368689, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.