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Floatation-REST (Reduced Environmental Stimulation Therapy) for Anxiety and Depression

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ClinicalTrials.gov Identifier: NCT03899090
Recruitment Status : Enrolling by invitation
First Posted : April 2, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Brief Summary:
This early-stage trial aims to examine the feasibility, tolerability, and safety of Floatation-REST (Reduced Environmental Stimulation Therapy) or an active comparison condition in 75 participants with clinical anxiety and depression.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder Agoraphobia Posttraumatic Stress Disorder Major Depressive Disorder Behavioral: Float pool Behavioral: Float chair Not Applicable

Detailed Description:
Anxiety and depression are the two most common psychiatric conditions, affecting over a quarter of the population, and representing the leading cause of disability, worldwide. More than three-quarters of patients never receive treatment, and recent meta-analyses and large-scale clinical trials suggest that only about half of patients improve with treatment, with substantially poorer outcomes and adherence in patients with comorbid anxiety and depression. Given the insufficient treatment response and adherence to currently available therapies, it is important to explore novel ways of helping patients with anxiety and depression. Floatation-REST (Reduced Environmental Stimulation Therapy) is a relatively unexplored mind-body intervention for naturally reducing physiological stress by attenuating exteroceptive sensory input to the nervous system through the act of floating supine in a pool of water saturated with Epsom salt (magnesium sulfate). Over the past decade, floating has witnessed a rapid rise in popularity, with hundreds of recreational float centers opening across America. Despite the surge in public interest and consumption, there has been little research investigation Floatation-REST, especially in clinical populations. The investigators recently completed several pilot studies in patients with comorbid anxiety and depression showing that a single float session was capable of inducing a large short-term anxiolytic and antidepressant response accompanied by a substantial improvement in mood and subjective well-being. This proposal aims to follow-up on these promising preliminary findings by investigating the feasibility, tolerability, and safety of undergoing multiple sessions of Floatation-REST or an active comparison condition in 75 participants with clinical anxiety and depression. A subset of these participants will have the opportunity to select their preference with regard to float duration and frequency, providing important information for optimizing the "dose" in future trials. Since this study is aimed at examining feasibility, tolerability, and safety, the primary endpoint is adherence (as a proxy of feasibility), and the secondary outcome measures are dropout rate (as a proxy for tolerability) and adverse effects (as a proxy for safety). An exploratory aim examines the magnitude and duration of the anxiolytic and antidepressant effects of Floatation-REST at both short-term (up to 48 hours) and long-term (up to 6 months) intervals, providing an initial indication for whether any beneficial effects are sustained beyond the float experience. The results of this early phase clinical trials will help optimize the design of a future efficacy study exploring the long-term effects of Floatation-REST.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants are randomized to one of three arms:

  1. floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
  2. floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
  3. floating supine in a pool for a preferred amount of time (6 total sessions, up to 2 hours/session, as frequently as they prefer within a 12-week period with a minimum of 24 hours between sessions)
Masking: Double (Participant, Investigator)
Masking Description: The investigator and participant are masked to study arm until after the participant completes their baseline session, at which point they are randomized using a sealed envelope.
Primary Purpose: Treatment
Official Title: Investigating Floatation-REST as a Novel Technique for Reducing Anxiety and Depression
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Float Pool
Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Behavioral: Float pool
Subject floats supine in a pool of water saturated with Epsom salt in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.

Active Comparator: Float Chair
Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Behavioral: Float chair
Subject floats supine in a zero-gravity chair in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.

Experimental: Float Pool Preferred
Floating supine in a pool for a preferred amount of time (6 total sessions, up to 2 hours/session, as frequently as they prefer within a 12-week period with a minimum of 24 hours between sessions)
Behavioral: Float pool
Subject floats supine in a pool of water saturated with Epsom salt in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.




Primary Outcome Measures :
  1. Adherence [ Time Frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm) ]

    As a proxy of feasibility, adherence for each subject = (# of sessions completed)/6.

    All subjects (in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.



Secondary Outcome Measures :
  1. Dropout rate [ Time Frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm) ]

    As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/25.

    All subjects (in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.


  2. Adverse effects [ Time Frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm) ]
    As a proxy of safety, adverse effects for each subject = # of instances during the study when a subject reports elevations above mild for any negative effects on the side effect checklist (administered after each float session)


Other Outcome Measures:
  1. Blood concentration (pg/mL) of proinflammatory cytokines (IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α) [ Time Frame: Blood samples collected at 3 time points: beginning of intervention (baseline), end of intervention (6-9 weeks after baseline), and at 6-week follow-up (12-15 weeks after baseline). ]
    At each time point, 10 cytokines will be measured in the blood as well as in response to a potent immune stressor (endotoxin)



Information from the National Library of Medicine

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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:

  1. High level of acute anxiety (OASIS score ≥ 8)
  2. High anxiety sensitivity (ASI-3 total score ≥ 29)
  3. If taking medication or receiving psychotherapy, must be stably undergoing treatment prior to participation (defined as having taken the medication or been in therapy for 8 weeks or longer). If taking a benzodiazepine or opioid, must be willing to abstain within 24 hours of a float session (daily users will be excluded from the study).
  4. No prior Floatation-REST experience or a minimum of 1 year since previous float session
  5. Seeking treatment for their anxiety/depression and willing to complete the study

Exclusion Criteria:

  1. History of Bipolar Disorder, Schizophrenia spectrum or other psychotic disorders
  2. Current Eating Disorder (anorexia/bulimia nervosa)
  3. Current Substance Use Disorder ≥ moderate. Tobacco and Caffeine Use is allowed. Must be willing to abstain from all other substances within 24 hours of a float session.
  4. Active suicidality with plan/intent
  5. History of a neurological condition (e.g., epilepsy) or any other medical condition that could interfere with the protocol
  6. Any skin conditions or open wounds that could cause pain when exposed to saltwater
  7. Uncomfortable being in water
  8. Positive pregnancy test
  9. Acutely intoxicated day of floating (determined via positive urine drug screen or breathalyzer)

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): NCT03899090


Locations
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United States, Oklahoma
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Justin Feinstein, PhD Principal Investigator

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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT03899090     History of Changes
Other Study ID Numbers: Float R34
R34AT009889 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the study results will be deidentified and shared with interested investigators using an online link
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Depression
Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Stress Disorders, Post-Traumatic
Panic Disorder
Phobia, Social
Agoraphobia
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Mood Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Phobic Disorders