Floatation-REST (Reduced Environmental Stimulation Therapy) for Anxiety and Depression (NCT03899090) | Clinical Trial Compass
UnknownNot Applicable
Floatation-REST (Reduced Environmental Stimulation Therapy) for Anxiety and Depression
United States75 participantsStarted 2019-04-08
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Adherence
Timeframe: Over 6-9 week period of intervention (up to 12 weeks for preferred pool arm)
Trial details
NCT IDNCT03899090
SponsorLaureate Institute for Brain Research, Inc.