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Behavioral Intervention

Floatation-REST for Anxiety and Depression

N/A
Waitlist Available
Led By Sahib Khalsa, MD, PhD
Research Sponsored by Laureate Institute for Brain Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights

Study Summary

This trial is testing a new therapy called Floatation-REST for people with clinical anxiety and depression. The goal is to see if it is safe and works well.

Who is the study for?
This trial is for individuals with anxiety or depression who haven't tried Floatation-REST before, or it's been at least a year since their last session. Participants should be on stable treatment if they're taking medication or in therapy and must avoid benzodiazepines and opioids 24 hours before floating. It's not for those with moderate to severe substance use (except tobacco/caffeine), pregnant women, certain mental health conditions like bipolar disorder, active suicidality, neurological issues that could affect the study, skin conditions painful in saltwater, or discomfort with water.Check my eligibility
What is being tested?
The trial tests Floatation-REST using a float chair or pool against an active comparison condition to see how well it works for people with clinical anxiety and depression. The goal is to assess its feasibility as a treatment option by enrolling 75 participants who will experience reduced environmental stimulation therapy.See study design
What are the potential side effects?
While specific side effects are not detailed here due to the nature of the intervention being non-pharmaceutical, potential side effects may include discomfort from prolonged stillness or silence during sessions, disorientation after floating sessions due to sensory deprivation experiences.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence
Secondary outcome measures
Adverse effects
Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)
Anxiety on the Brief Symptom Inventory-18
+22 more
Other outcome measures
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)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Float Pool PreferredExperimental Treatment1 Intervention
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)
Group II: Float PoolExperimental Treatment1 Intervention
Floating supine in a pool for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)
Group III: Float ChairActive Control1 Intervention
Floating supine in a zero-gravity chair for a prescribed amount of time (6 total sessions, 1 hour/session, 1 session/week)

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,669 Total Patients Enrolled
7 Trials studying Generalized Anxiety Disorder
552 Patients Enrolled for Generalized Anxiety Disorder
Laureate Institute for Brain Research, Inc.Lead Sponsor
51 Previous Clinical Trials
5,350 Total Patients Enrolled
4 Trials studying Generalized Anxiety Disorder
348 Patients Enrolled for Generalized Anxiety Disorder
Sahib Khalsa, MD, PhDPrincipal InvestigatorPrincipal Investigator
3 Previous Clinical Trials
215 Total Patients Enrolled
~12 spots leftby Jun 2025