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

• ClinicalTrials.gov Identifier: NCT03899090
• Recruitment Status: Active, not recruiting
• First Posted: April 2, 2019
• Last Update Posted: May 5, 2022
• Sponsor: Laureate Institute for Brain Research, Inc.
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Laureate Institute for Brain Research, Inc.

Tracking Information

• First Submitted Date: March 4, 2019
• First Posted Date: April 2, 2019
• Last Update Posted Date: May 5, 2022
• Actual Study Start Date: April 8, 2019
• Estimated Primary Completion Date: October 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2019)

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(in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 3, 2022)

• 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  As a proxy for tolerability, dropout rate for each arm = (# of subjects who are withdrawn from the study)/25.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(in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.
• 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)
• Psychological Distress on the Brief Symptom Inventory-18 [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Total Score on the Brief Symptom Inventory-18 [Average change pre to post-intervention]
• Anxiety on the Brief Symptom Inventory-18 [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Anxiety subscale [Average change pre to post-intervention]
• Depression on the Brief Symptom Inventory-18 [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Depression subscale [Average change pre to post-intervention]
• Somatization on the Brief Symptom Inventory-18 [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Somatization subscale [Average change pre to post-intervention]
• Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Total score [Average change pre to post-intervention]
• Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS) [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Total score [Average change pre to post-intervention]
• Disability on the Sheehan Disability Scale [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Total score [Average change pre to post-intervention]
• Anxiety remission [ Time Frame: An average of 6 weeks after the final float session ]
  Percent of individuals by condition (chair, pool, pool-preferred) who have a HAM-A score of ≤ 7
• Anxiety responder [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  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)
• Depression remission [ Time Frame: An average of 6 weeks after the final float session ]
  Percent of individuals by condition (chair, pool, pool-preferred) who have a MADRS score of ≤ 9
• Depression responder [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Percent of individuals by condition (chair, pool, pool-preferred) who show a 50% reduction on MADRS or Patient Health Questionnaire-9 (PHQ-9)
• Depression on the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Total score [Average change pre to post-intervention]
• Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Total score [Average change pre to post-intervention]
• Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R) [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Total score [Average change pre to post-intervention]
• Positive Affect on the Positive and Negative Affect Schedule-X (PANAS-X) [ Time Frame: Through completion of the final float session ]
  Average of Positive Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
• Negative Affect on the Positive and Negative Affect Schedule-X (PANAS-X) [ Time Frame: Through completion of the final float session ]
  Average of Negative Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
• Serenity on the Positive and Negative Affect Schedule-X (PANAS-X) [ Time Frame: Through completion of the final float session ]
  Average of Serenity rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
• State Anxiety on the State Trait Anxiety Inventory (STAI) [ Time Frame: Through completion of the final float session ]
  Average of STAI State Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
• Muscle Tension rating on the Visual Analog Scale (VAS) [ Time Frame: Through completion of the final float session ]
  Average of VAS muscle tension rating change scores from pre-to-post float all six floats for each condition (chair, pool, pool-preferred)
• Pain on the Wong-Baker Pain Scale (WBPS) [ Time Frame: Through completion of the final float session ]
  Average of WBPS rating change from pre-to-post float across all six floats for each condition
• Trait Anxiety on the State Trait Anxiety Inventory [ Time Frame: Through study completion, an average of 6 months after the final float session ]
  Average of STAI Trait Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
• Cardiac interoceptive accuracy [ Time Frame: Through completion of the final float session ]
  Average of Beat-to-squeeze consistency on cardiac interoception task
• Heartbeat perception rating [ Time Frame: Through completion of the final float session ]
  Average of heartbeat intensity, task difficulty, and task accuracy ratings

Original Secondary Outcome Measures (submitted: March 29, 2019)

• 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.
• 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)

Current Other Pre-specified Outcome Measures (submitted: April 1, 2019)

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)

Original Other Pre-specified Outcome Measures (submitted: March 29, 2019)

Proinflammatory cytokines in blood (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)

Descriptive Information

• Brief Title: Floatation-REST (Reduced Environmental Stimulation Therapy) for Anxiety and Depression
• Official Title: Investigating Floatation-REST as a Novel Technique for Reducing Anxiety and Depression
• 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.
• 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
• Study Phase: Not Applicable

Study Design

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

Condition

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

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.
• 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.

Study Arms

• Experimental: Float Pool
  Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
  Intervention: Behavioral: Float pool
• 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)
  Intervention: Behavioral: Float chair
• 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)
  Intervention: Behavioral: Float pool

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 29, 2019): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: October 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03899090
• Other Study ID Numbers: Float R34; R34AT009889 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

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
• Supporting Materials: 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

• Current Responsible Party: Laureate Institute for Brain Research, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Laureate Institute for Brain Research, Inc.
• Original Study Sponsor: Same as current
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Sahib Khalsa, MD, PhD; Principal Investigator

• PRS Account: Laureate Institute for Brain Research, Inc.
• Verification Date: May 2022