RESUMEN
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.
Asunto(s)
Ansiedad , Depresión , Estudios de Factibilidad , Humanos , Masculino , Femenino , Adulto , Ansiedad/terapia , Depresión/terapia , Persona de Mediana Edad , Método Simple Ciego , Resultado del Tratamiento , Terapia Conductista/métodosRESUMEN
Background: Reduced Environmental Stimulation Therapy via floatation (floatation-REST) is a behavioral intervention designed to attenuate exteroceptive sensory input to the nervous system. Pilot studies in anxious and depressed individuals demonstrated that single sessions of floatation-REST are safe, well-tolerated, and associated with acute anxiolysis. However, there is not sufficient evidence of the feasibility of floatation-REST as a repeated intervention. Methods: We randomized 75 individuals with anxiety and depression to six sessions of floatation-REST in different formats (pool-REST or pool-REST preferred) or an active comparator (chair-REST). Feasibility was assessed via adherence rate to the assigned intervention, tolerability via duration of REST utilization and overall study dropout rate, and safety via incidence of serious or non-serious adverse events. Results: Six-session adherence was 85% for pool-REST, 89% for pool-REST preferred, and 74% for chair-REST. Dropout rates did not differ significantly between the treatment conditions. Mean session durations were consistently above 50 minutes, and when allowed to choose the duration and frequency, participants opted to float for an average of 75 minutes. 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: Taken together, 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.
RESUMEN
Background: Reduced Environmental Stimulation Therapy (REST) is a behavioral intervention that systematically attenuates external sensory input to the nervous system. Previous studies have demonstrated acute anxiolytic and antidepressant effects of single sessions of REST in anxious individuals, however the duration and time course of these effects is unknown. In the current study, we used experience sampling and multiple sessions of REST to explore the time course of the anxiolytic and antidepressant effects over a 48-hour time period. Methods: 75 adults with anxiety and/or depression were randomized to complete 6 sessions of REST (either pool-REST, pool-REST preferred, or chair-REST). Post-REST effects were tracked using experience sampling on a smartphone with a ten-item survey administered at 6 time points for each session (i.e., immediately before and after REST and then 4, 8, 24, and 48 hours later). Using principal component analysis, responses to survey items at baseline were reduced to broad symptom clusters of anxiety, depression, and serenity and were utilized in linear mixed effects models to determine the magnitude and time course of post-REST effects. Results: REST was associated with significant decreases in anxiety and depression, and significant increases in serenity, with effects lasting for 48 hours. Repeated exposure to REST was associated with lower baseline levels of anxiety at later sessions. Conclusion: These initial findings suggest that the anxiolytic and antidepressant effects of REST persist for at least two days, and that repeated REST sessions may have additive effects on lowering anxiety-related symptoms. These findings could help to determine the optimal intervention frequency of REST and facilitate future investigations focused on the combination of REST with standard treatments for anxiety and depression.