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

Investigating Floatation-REST as a Novel Technique for Reducing Anxiety and Depression

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Generalized Anxiety Disorder; Major Depressive Disorder; Posttraumatic Stress Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia
• Intervention / Treatment: Behavioral: Float pool; Behavioral: Float chair

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Laureate Institute for Brain Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. High level of acute anxiety (OASIS score ≥ 6)
2. High anxiety sensitivity (ASI-3 total score ≥ 24)
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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	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.	Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dropout rate	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.	Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Adverse effects	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)	Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Psychological Distress on the Brief Symptom Inventory-18	Total Score on the Brief Symptom Inventory-18 [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Anxiety on the Brief Symptom Inventory-18	Anxiety subscale [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Depression on the Brief Symptom Inventory-18	Depression subscale [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Somatization on the Brief Symptom Inventory-18	Somatization subscale [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)	Total score [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)	Total score [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Disability on the Sheehan Disability Scale	Total score [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Anxiety remission	Percent of individuals by condition (chair, pool, pool-preferred) who have a HAM-A score of ≤ 7	An average of 6 weeks after the final float session
Anxiety responder	Percent of individuals by condition (chair, pool, pool-preferred) who show a 50% reduction on HAM-A or Overall Anxiety Severity and Impairment Scale (OASIS)	Through study completion, an average of 6 months after the final float session
Depression remission	Percent of individuals by condition (chair, pool, pool-preferred) who have a MADRS score of ≤ 9	An average of 6 weeks after the final float session
Depression responder	Percent of individuals by condition (chair, pool, pool-preferred) who show a 50% reduction on MADRS or Patient Health Questionnaire-9 (PHQ-9)	Through study completion, an average of 6 months after the final float session
Depression on the Patient Health Questionnaire-9 (PHQ-9)	Total score [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)	Total score [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)	Total score [Average change pre to post-intervention]	Through study completion, an average of 6 months after the final float session
Positive Affect on the Positive and Negative Affect Schedule-X (PANAS-X)	Average of Positive Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)	Through completion of the final float session
Negative Affect on the Positive and Negative Affect Schedule-X (PANAS-X)	Average of Negative Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)	Through completion of the final float session
Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)	Average of Serenity rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)	Through completion of the final float session
State Anxiety on the State Trait Anxiety Inventory (STAI)	Average of STAI State Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)	Through completion of the final float session
Muscle Tension rating on the Visual Analog Scale (VAS)	Average of VAS muscle tension rating change scores from pre-to-post float all six floats for each condition (chair, pool, pool-preferred)	Through completion of the final float session
Pain on the Wong-Baker Pain Scale (WBPS)	Average of WBPS rating change from pre-to-post float across all six floats for each condition	Through completion of the final float session
Trait Anxiety on the State Trait Anxiety Inventory	Average of STAI Trait Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)	Through study completion, an average of 6 months after the final float session
Cardiac interoceptive accuracy	Average of Beat-to-squeeze consistency on cardiac interoception task	Through completion of the final float session
Heartbeat perception rating	Average of heartbeat intensity, task difficulty, and task accuracy ratings	Through completion of the final float session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At each time point, 10 cytokines will be measured in the blood as well as in response to a potent immune stressor (endotoxin)	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).

Collaborators and Investigators

• Sponsor: Laureate Institute for Brain Research, Inc.
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Sahib Khalsa, MD, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): May 30, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Trauma and Stressor Related Disorders; Phobic Disorders; Stress Disorders, Traumatic; Depressive Disorder; Anxiety Disorders; Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Phobia, Social; Panic Disorder; Agoraphobia
• Other Study ID Numbers: Float R34; R34AT009889 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the study results will be deidentified and shared with interested investigators using an online link
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No