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Data from: A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals

Garland, McKenna1; Wilson, Raminta1; Thompson, Wesley1; Stein, Murray2; Paulus, Martin1; Feinstein, Justin3; Khalsa, Sahib1

Research facility: Laureate Institute for Brain Research
Published Feb 09, 2024 on Dryad. https://doi.org/10.5061/dryad.0k6djhb75

Data files

Feb 09, 2024 version files 345.31 KB

Abstract

Background: Reduced Environmental Stimulation Therapy via floatation (floatation- REST) is a behavioral intervention designed to attenuate exteroceptive sensory input to the nervous system. Prior studies in anxious and depressed individuals demonstrated that single sessions of floatation-REST are safe, well-tolerated, and associated with an acute anxiolytic and antidepressant effect that persists for over 48 hours. However, the feasibility of using floatation-REST as a repeated intervention in anxious and depressed populations has not been well-investigated.

Methods: In this single-blind safety and feasibility trial, 75 individuals with anxiety and depression were randomized to complete six sessions of floatation-REST in different formats: pool-REST (weekly 1-hour float sessions), pool-REST preferred (float sessions with flexibility of duration and frequency), or an active comparator (chair- REST; weekly 1-hour sessions in a Zero Gravity chair). Feasibility (primary outcome) was assessed via an 80% rate of adherence to the assigned intervention; tolerability via study dropout and duration/frequency of REST utilization; and safety via incidence of adverse events and ratings about the effects of REST.

Results: Of 1,715 individuals initially screened, 75 participants were ultimately randomized. Six-session adherence was 85% for pool-REST (mean, M=5.1 sessions; standard deviation, SD=1.8), 89% for pool-REST preferred (M=5.3 sessions; SD=1.6), and 74% for chair-REST (M=4.4 sessions; SD=2.5). Dropout rates at the end of the intervention did not differ significantly between the treatment conditions. Mean session durations were 53.0 minutes (SD=12.3) for pool-REST, 75.4 minutes (SD=29.4) for pool-REST preferred, and 58.4 minutes (SD=4.3) for chair-REST. There were no serious adverse events associated with any intervention. Positive experiences were endorsed more commonly than negative ones and were also rated at higher levels of intensity.

Conclusions: Six sessions of floatation-REST appear feasible, well-tolerated, and safe in anxious and depressed individuals. Floatation-REST induces positively-valenced experiences with few negative effects. Larger randomized controlled trials evaluating markers of clinical efficacy are warranted.

Clinical Trial Registration Identifier: NCT03899090