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

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