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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Examining the Effects of Reduced Environmental Stimulation on the Brain

NCT02452203

Anxiety

COMPLETED NA

A Pilot Study of Cranial Electrotherapy Stimulation[CES] for Generalized Anxiety Disorder

NCT00539357

Generalized Anxiety Disorder

COMPLETED PHASE4

Muscle Relaxation Therapy With Odorant Cue

NCT00208910

Generalized Anxiety Disorder Anxiety

COMPLETED NA

VR Relaxation in Older Adults With Mental Illness

NCT06973941

Mental Disorder

COMPLETED NA

Feasibility of a Mental-Health Intervention Based on Contemplative Sleep Practices

NCT07217340

Anxiety

ACTIVE_NOT_RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder Agoraphobia Posttraumatic Stress Disorder Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Float Pool

Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)

Group Type EXPERIMENTAL

Float pool

Intervention Type BEHAVIORAL

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.

Float Chair

Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)

Group Type ACTIVE_COMPARATOR

Float chair

Intervention Type BEHAVIORAL

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.

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)

Group Type EXPERIMENTAL

Float pool

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No