Data from: A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals
Data files
Feb 09, 2024 version files 345.31 KB
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Dryad_Data_V2.xlsx
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README.md
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
README: 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.
https://doi.org/10.5061/dryad.0k6djhb75
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
- Number of variables: 9
- Number of cases/rows: 76
- Missing data codes: NA
- 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
- Number of variables: 5
- Number of cases/rows: 71
- Missing data codes: NA
- Variable List:
- ID: subject ID # (random value)
- Credibility_1: Credibility item 1 on the Credibility expectancy questionnaire >> "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 >> "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 >> "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 >> "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
- Number of variables: 4
- Number of cases/rows: 16413
- Missing data codes: NA
- 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
- Number of variables: 3
- Number of cases/rows: 379
- Missing data codes: NA
- 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
- Number of variables: 3
- Number of cases/rows: 451
- Missing data codes: NA
- 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
- Number of variables: 7
- Number of cases/rows: 76
- Missing data codes: NA
- 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