An interventional study of Float pool and Float chair in Generalized Anxiety Disorder, Social Anxiety Disorder and Panic Disorder, sponsored by Laureate Institute for Brain Research, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Laureate Institute for Brain Research, Inc. · Not applicable, Interventional, and Treatment
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.
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.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's enrollment of 75 is close to the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Laureate Institute for Brain Research, Inc. is the lead sponsor of 54 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Behavioral: Float pool
Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Behavioral: Float chair
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)
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.
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.
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.
Time frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
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.
Time frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
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)
Time frame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Psychological Distress on the Brief Symptom Inventory-18
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
Anxiety on the Brief Symptom Inventory-18
Anxiety subscale \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Depression on the Brief Symptom Inventory-18
Depression subscale \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Somatization on the Brief Symptom Inventory-18
Somatization subscale \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)
Total score \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)
Total score \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Disability on the Sheehan Disability Scale
Total score \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety remission
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
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)
Time frame: Through study completion, an average of 6 months after the final float session
Depression remission
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
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)
Time frame: Through study completion, an average of 6 months after the final float session
Depression on the Patient Health Questionnaire-9 (PHQ-9)
Total score \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)
Total score \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)
Total score \[Average change pre to post-intervention\]
Time frame: Through study completion, an average of 6 months after the final float session
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)
Time frame: Through completion of the final float session
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)
Time frame: Through completion of the final float session
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)
Time frame: Through completion of the final float session
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)
Time frame: Through completion of the final float session
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)
Time frame: Through completion of the final float session
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
Time frame: Through completion of the final float session
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)
Time frame: Through study completion, an average of 6 months after the final float session
Cardiac interoceptive accuracy
Average of Beat-to-squeeze consistency on cardiac interoception task
Time frame: Through completion of the final float session
Heartbeat perception rating
Average of heartbeat intensity, task difficulty, and task accuracy ratings
Time frame: Through completion of the final float session
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)
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).
Plan to share: Yes — Individual participant data that underlie the study results will be deidentified and shared with interested investigators using an online link
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Researchers who provide a methodologically sound proposal
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in May 2023, 49 months.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 49 months is above that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →
Laureate Institute for Brain Research, Inc.