Floatation-REST (Reduced Environmental Stimulation Therapy) for Anxiety and Depression
Primary Purpose
Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Float pool
Float chair
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- High level of acute anxiety (OASIS score ≥ 6)
- High anxiety sensitivity (ASI-3 total score ≥ 24)
- 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).
- No prior Floatation-REST experience or a minimum of 1 year since previous float session
- Seeking treatment for their anxiety/depression and willing to complete the study
Exclusion Criteria:
- History of Bipolar Disorder, Schizophrenia spectrum or other psychotic disorders
- Current Eating Disorder (anorexia/bulimia nervosa)
- 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.
- Active suicidality with plan/intent
- History of a neurological condition (e.g., epilepsy) or any other medical condition that could interfere with the protocol
- Any skin conditions or open wounds that could cause pain when exposed to saltwater
- Uncomfortable being in water
- Positive pregnancy test
- Acutely intoxicated day of floating (determined via positive urine drug screen or breathalyzer)
Sites / Locations
- Laureate Institute for Brain Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Float Pool
Float Chair
Float Pool Preferred
Arm Description
Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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)
Psychological Distress on the Brief Symptom Inventory-18
Total Score on the Brief Symptom Inventory-18 [Average change pre to post-intervention]
Anxiety on the Brief Symptom Inventory-18
Anxiety subscale [Average change pre to post-intervention]
Depression on the Brief Symptom Inventory-18
Depression subscale [Average change pre to post-intervention]
Somatization on the Brief Symptom Inventory-18
Somatization subscale [Average change pre to post-intervention]
Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)
Total score [Average change pre to post-intervention]
Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)
Total score [Average change pre to post-intervention]
Disability on the Sheehan Disability Scale
Total score [Average change pre to post-intervention]
Anxiety remission
Percent of individuals by condition (chair, pool, pool-preferred) who have a HAM-A score of ≤ 7
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)
Depression remission
Percent of individuals by condition (chair, pool, pool-preferred) who have a MADRS score of ≤ 9
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)
Depression on the Patient Health Questionnaire-9 (PHQ-9)
Total score [Average change pre to post-intervention]
Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)
Total score [Average change pre to post-intervention]
Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)
Total score [Average change pre to post-intervention]
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)
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)
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)
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)
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)
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
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)
Cardiac interoceptive accuracy
Average of Beat-to-squeeze consistency on cardiac interoception task
Heartbeat perception rating
Average of heartbeat intensity, task difficulty, and task accuracy ratings
Full Information
NCT ID
NCT03899090
First Posted
March 4, 2019
Last Updated
October 4, 2023
Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT03899090
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Posttraumatic Stress Disorder, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of three arms:
floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Float Pool
Arm Type
Experimental
Arm Description
Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Arm Title
Float Chair
Arm Type
Active Comparator
Arm Description
Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Arm Title
Float Pool Preferred
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Float pool
Intervention Description
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
Intervention Name(s)
Float chair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Secondary Outcome Measure Information:
Title
Dropout rate
Description
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.
Time Frame
Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Title
Adverse effects
Description
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)
Time Frame
Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Title
Psychological Distress on the Brief Symptom Inventory-18
Description
Total Score on the Brief Symptom Inventory-18 [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Anxiety on the Brief Symptom Inventory-18
Description
Anxiety subscale [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Depression on the Brief Symptom Inventory-18
Description
Depression subscale [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Somatization on the Brief Symptom Inventory-18
Description
Somatization subscale [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)
Description
Total score [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)
Description
Total score [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Disability on the Sheehan Disability Scale
Description
Total score [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Anxiety remission
Description
Percent of individuals by condition (chair, pool, pool-preferred) who have a HAM-A score of ≤ 7
Time Frame
An average of 6 weeks after the final float session
Title
Anxiety responder
Description
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)
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Depression remission
Description
Percent of individuals by condition (chair, pool, pool-preferred) who have a MADRS score of ≤ 9
Time Frame
An average of 6 weeks after the final float session
Title
Depression responder
Description
Percent of individuals by condition (chair, pool, pool-preferred) who show a 50% reduction on MADRS or Patient Health Questionnaire-9 (PHQ-9)
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Depression on the Patient Health Questionnaire-9 (PHQ-9)
Description
Total score [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)
Description
Total score [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)
Description
Total score [Average change pre to post-intervention]
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Positive Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
Description
Average of Positive Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Time Frame
Through completion of the final float session
Title
Negative Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
Description
Average of Negative Affect rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Time Frame
Through completion of the final float session
Title
Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)
Description
Average of Serenity rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Time Frame
Through completion of the final float session
Title
State Anxiety on the State Trait Anxiety Inventory (STAI)
Description
Average of STAI State Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Time Frame
Through completion of the final float session
Title
Muscle Tension rating on the Visual Analog Scale (VAS)
Description
Average of VAS muscle tension rating change scores from pre-to-post float all six floats for each condition (chair, pool, pool-preferred)
Time Frame
Through completion of the final float session
Title
Pain on the Wong-Baker Pain Scale (WBPS)
Description
Average of WBPS rating change from pre-to-post float across all six floats for each condition
Time Frame
Through completion of the final float session
Title
Trait Anxiety on the State Trait Anxiety Inventory
Description
Average of STAI Trait Anxiety rating change scores from pre-to-post float across all six floats for each condition (chair, pool, pool-preferred)
Time Frame
Through study completion, an average of 6 months after the final float session
Title
Cardiac interoceptive accuracy
Description
Average of Beat-to-squeeze consistency on cardiac interoception task
Time Frame
Through completion of the final float session
Title
Heartbeat perception rating
Description
Average of heartbeat intensity, task difficulty, and task accuracy ratings
Time Frame
Through completion of the final float session
Other Pre-specified Outcome Measures:
Title
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)
Description
At each time point, 10 cytokines will be measured in the blood as well as in response to a potent immune stressor (endotoxin)
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High level of acute anxiety (OASIS score ≥ 6)
High anxiety sensitivity (ASI-3 total score ≥ 24)
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).
No prior Floatation-REST experience or a minimum of 1 year since previous float session
Seeking treatment for their anxiety/depression and willing to complete the study
Exclusion Criteria:
History of Bipolar Disorder, Schizophrenia spectrum or other psychotic disorders
Current Eating Disorder (anorexia/bulimia nervosa)
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.
Active suicidality with plan/intent
History of a neurological condition (e.g., epilepsy) or any other medical condition that could interfere with the protocol
Any skin conditions or open wounds that could cause pain when exposed to saltwater
Uncomfortable being in water
Positive pregnancy test
Acutely intoxicated day of floating (determined via positive urine drug screen or breathalyzer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahib Khalsa, MD, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Floatation-REST (Reduced Environmental Stimulation Therapy) for Anxiety and Depression
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