NCT03899090

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Laureate Institute for Brain Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-04-08
• Primary completion: 2023-05-30
• Completion: 2024-05-31
• First posted: 2019-04-02
• Last updated: 2023-10-05

Locations

1 site across 1 country: United States