Clinical trial NCT03899090: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Agoraphobia
Posttraumatic Stress Disorder
Major Depressive Disorder
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-04-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Adherence
timeFrame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Secondary outcomes:
measure: Dropout rate
timeFrame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
measure: Adverse effects
timeFrame: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
measure: Psychological Distress on the Brief Symptom Inventory-18
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Anxiety on the Brief Symptom Inventory-18
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Depression on the Brief Symptom Inventory-18
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Somatization on the Brief Symptom Inventory-18
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Anxiety on the clinician-rated Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Depression on the clinician-rated Montgomery Åsberg Rating Scale (MADRS)
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Disability on the Sheehan Disability Scale
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Anxiety remission
timeFrame: An average of 6 weeks after the final float session
measure: Anxiety responder
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Depression remission
timeFrame: An average of 6 weeks after the final float session
measure: Depression responder
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Depression on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Anxiety on the Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Positive Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
timeFrame: Through completion of the final float session
measure: Negative Affect on the Positive and Negative Affect Schedule-X (PANAS-X)
timeFrame: Through completion of the final float session
measure: Serenity on the Positive and Negative Affect Schedule-X (PANAS-X)
timeFrame: Through completion of the final float session
measure: State Anxiety on the State Trait Anxiety Inventory (STAI)
timeFrame: Through completion of the final float session
measure: Muscle Tension rating on the Visual Analog Scale (VAS)
timeFrame: Through completion of the final float session
measure: Pain on the Wong-Baker Pain Scale (WBPS)
timeFrame: Through completion of the final float session
measure: Trait Anxiety on the State Trait Anxiety Inventory
timeFrame: Through study completion, an average of 6 months after the final float session
measure: Cardiac interoceptive accuracy
timeFrame: Through completion of the final float session
measure: Heartbeat perception rating
timeFrame: Through completion of the final float session
Other outcomes:
measure: 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)
timeFrame: 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).
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Principal Investigator
name: Sahib Khalsa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: