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

NCT03899090 | Unknown DMC

• 2 other identifiers: Float R34R34AT009889
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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(in all arms of the study) are given up to 3 opportunities to reschedule missed appointments, after which they are withdrawn from the study.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 Outcomes (25)

• Dropout rate

  Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)

• Adverse effects

  Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)

• Psychological Distress on the Brief Symptom Inventory-18

  Through study completion, an average of 6 months after the final float session

• Anxiety on the Brief Symptom Inventory-18

  Through study completion, an average of 6 months after the final float session

• Depression on the Brief Symptom Inventory-18

  Through study completion, an average of 6 months after the final float session

Other Outcomes (1)

• 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)

  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).

Study Arms (3)

Float Pool

EXPERIMENTAL

Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)

Behavioral: Float pool

Float Chair

ACTIVE COMPARATOR

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

Float Pool Preferred

EXPERIMENTAL

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

Interventions

Float pool BEHAVIORAL

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 Pool; Float Pool Preferred

Float chair BEHAVIORAL

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.

Float Chair

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Related Publications (2)

• Garland MM, Wilson R, Thompson WK, Stein MB, Paulus MP, Feinstein JS, Khalsa SS. A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals. PLoS One. 2024 Jun 6;19(6):e0286899. doi: 10.1371/journal.pone.0286899. eCollection 2024.

  PMID: 38843272 DERIVED

• Garland MM, Wilson R, Thompson WK, Stein MB, Paulus MP, Feinstein JS, Khalsa SS. A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals. medRxiv [Preprint]. 2023 Jun 8:2023.05.27.23290633. doi: 10.1101/2023.05.27.23290633.

  PMID: 37333146 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Sahib Khalsa, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: April 2, 2019
• Study Start: April 8, 2019
• Primary Completion: May 30, 2023
• Study Completion: May 31, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)