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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03899090
• Other study ID #: Float R34
• Secondary ID: R34AT009889
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2023
• Source: Laureate Institute for Brain Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: May 31, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorders
• Depressive Disorder
• Depressive Disorder, Major
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Panic Disorder
• Phobia, Social
• Posttraumatic Stress Disorder
• Social Anxiety Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Laureate Institute for Brain Research, Inc.	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood concentration (pg/mL) of proinflammatory cytokines (IFN-?, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-a)	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).
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cardiac interoceptive accuracy	Average of Beat-to-squeeze consistency on cardiac interoception task	Through completion of the final float session
Secondary	Heartbeat perception rating	Average of heartbeat intensity, task difficulty, and task accuracy ratings	Through completion of the final float session