DOI: 10.5061/dryad.0k6djhb75
title: Data from: A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals

description: 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
description: # General Information 1\. Title of Dataset: A randomized controlled safety
 and feasibility trial of floatation-REST in anxious and depressed
 individuals 2\. Author Information ``` A. Principal Investigator Contact
 Information Name: Sahib Khalsa, M.D., Ph.D. Institution: Laureate
 Institute for Brain Research Address: 6565 S Yale Ave. Tulsa, OK 74136
 Email: skhalsa@laureateinstitute.org ``` 3\. Date of data collection:
 February 2019 - October 2021 4\. Geographic location of data collection:
 Laureate Institute for Brain Research, Tulsa, OK 5\. Information about
 funding sources that supported the collection of the data: This research
 was supported by an award from the National Center for Complimentary and
 Integrative Health (R34AT009889). The authors were also supported by the
 National Institute of Mental Health (R01MH127225, K23MH112949 to SSK),
 National Institute of General Medical Sciences Center Grant Award Number
 (1P20GM121312 to MPP, JSF, SSK), and The William K. Warren Foundation. The
 funding sources had no role in the design and conduct of the study;
 collection, management, analysis, and interpretation of the data;
 preparation, review, or approval of the manuscript; or decision to submit
 the manuscript for publication. There was no additional external funding
 received for this study. 
 ## Sharing/Access Information ``` Links to other publicly accessible
 locations of the data: NA Data was derived from the following sources: NA
 ``` ## Description of the data and file structure Excel data file
 (Dryad_Data.xlsx) contains 6 sheets (described in detail below).
 DATA-SPECIFIC INFORMATION FOR: Sheet 1 Demographics 1. Number of
 variables: 9 2. Number of cases/rows: 76 3. Missing data codes: NA 4.
 Variable List: * ID: subject ID # (random value) * Condition: assigned
 floatation-REST condition (Pool, Pool Preferred, or Control); Control =
 Chair (as described in manuscript) * Sex: patient reported biological sex
 * Psychotropics: # of psychotropic medications on participant's
 medication list * Education: years of education * Age: age range at
 baseline (exact age was modified to age range in accordance with
 Dryad's policy on publishing indirect identifiers) * OASIS.Baseline:
 total score on The Overall Anxiety Severity and Impairment Scale (OASIS)
 at baseline measurement * PHQ9.Baseline: total score on the Patient Health
 Questionnaire (PHQ-9) at baseline measurement * ASI.Baseline: total score
 on the Anxiety Sensitivity Index (ASI-3R) at baseline measurement *Note:
 Race/ethnicity and DSM-5 diagnosis were removed from the data set in
 accordance with Dryad's policy on the publishing of indirect
 identifiers. Participant's BMI was also removed as a variable from
 the current data set in accordance with Dryad's policy on publishing
 direct identifiers. DATA-SPECIFIC INFORMATION FOR: Sheet 2 CEQ 1. Number
 of variables: 5 2. Number of cases/rows: 71 3. Missing data codes: NA 4.
 Variable List: * ID: subject ID # (random value) * Credibility_1:
 Credibility item 1 on the Credibility expectancy questionnaire &gt;&gt;
 "At this point, how logical does the therapy offered to you
 seem?"; Rated on scale from 1 "Not at all logical" to 9
 "Very logical" * Credibility_2: Credibility item 2 on the
 Credibility expectancy questionnaire &gt;&gt; "At this point, how
 successfully do you think this treatment will be in reducing your
 symptoms?"; Rated on scale from 1 "Not at all successful"
 to 9 "Very successful" * Credibility_3: Credibility item 3 on
 the Credibility expectancy questionnaire &gt;&gt; "How confident
 would you be in recommending this treatment to a friend who experiences
 similar problems?"; Rated on scale from 1 "Not at all
 confident" to 9 "Very confident" * Expectancy: Expectancy
 item on the Credibility expectancy questionnaire &gt;&gt; "By the end
 of the therapy period, how much improvement in your symptoms do you think
 will occur?"; Rated on scale from 0% to 100% DATA-SPECIFIC
 INFORMATION FOR: Sheet 3 Event Checklist 1. Number of variables: 4 2.
 Number of cases/rows: 16413 3. Missing data codes: NA 4. Variable List: *
 ID: subject ID # (random value) * Visit: REST session 1-6 * SideEffect:
 side effect item on the Event Checklist * Response: participant response
 to side effect item; items rated as “none” were coded as 0, negatively
 experienced items ranged from -3 (“extremely negative”) to -1 (“mildly
 negative”), and positively experienced items ranged from 1 (“mildly
 positive) to 3 (“extremely positive”).  DATA-SPECIFIC INFORMATION FOR:
 Sheet 4 Session Duration 1. Number of variables: 3 2. Number of
 cases/rows: 379 3. Missing data codes: NA 4. Variable List: * ID: subject
 ID # (random value) * Visit: REST session 1-6 * Duration: duration in
 minutes of REST session DATA-SPECIFIC INFORMATION FOR: Sheet 5 Adherence
 1. Number of variables: 3 2. Number of cases/rows: 451 3. Missing data
 codes: NA 4. Variable List: * ID: subject ID # (random value) * Visit:
 REST session 1-6 * Completed_Visit: No: participant did not complete
 visit; Yes: participant completed visit DATA-SPECIFIC INFORMATION FOR:
 Sheet 6 Days Between Sessions 1. Number of variables: 7 2. Number of
 cases/rows: 76 3. Missing data codes: NA 4. Variable List: * ID: subject
 ID # (random value) * DaysSinceBaselineFloat: # of days since
 participant's baseline visit * DaysSinceFloat1: # of days since
 participant's REST session 1 * DaysSinceFloat2: # of days since
 participant's REST session 2 * DaysSinceFloat3: # of days since
 participant's REST session 3 * DaysSinceFloat4: # of days since
 participant's REST session 4 * DaysSinceFloat5: # of days since
 participant's REST session 5