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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

Must not have

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

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition like epilepsy that might affect the study.

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I have skin conditions or open wounds that saltwater could irritate.

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I have an eating disorder like anorexia or bulimia.

Timeline

Screening ~ 3 weeks3 visits

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).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence

Secondary study objectives

Adverse effects

Anxiety Sensitivity on the Anxiety Sensitivity Index-3R (ASI-3R)

Anxiety on the Brief Symptom Inventory-18

+22 more

Other study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 3Eligibility criteria met