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CompletedNCT06197464Updated Apr 17, 2024

FLOAT Through Anxiety: Virtual Reality Application's Efficacy as a Tool to Distract From Negative Emotions and Thoughts

An interventional study of psychoeducation on emotional regulation and distraction strategy and Using the FLOAT app on a virtual reality device in Control and Experimental, sponsored by University of Haifa. Completed at 1 site in Israel. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by University of Haifa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2023, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The goal of this clinical trial is to examine the effectiveness and safety of the VR FLOAT application as a tool to reduce negative thoughts and feelings and anxiety symptoms in students with high levels of stress and anxiety. The main questions it aims to answer are:

  1. Will subjects with high levels of anxiety who will use the FLOAT application experience a more significant relief in feelings of anxiety compared to subjects in the control group?
  2. Will subjects who are used to using technology find greater comfort in using VR compared to subjects who are not used to it?
  3. What is the degree of satisfaction with the use of VR and are there any reports of side effects?Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets Researchers will compare control group to see The comparison between using FLOAT as a regulation strategy after psychoeducation on emotional regulation and cognitive-behavioral use of a regulation strategy after the same psychoeducation
02

Conditions studied

  • Control
  • Experimental
03

In context

Lead sponsor

University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 'moderate' or 'severe' levels of stress and/or anxiety according to the DASS-21 questionnaire
  • student

Exclusion criteria

Exclusion Criteria:

  • under the age of 18
  • diagnoses of schizophrenia or bipolar disorder, including past or present psychotic conditions
  • suicidality
  • pregnant women
  • do not speak or read Hebrew fluently
  • a diagnosis of epilepsy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    control

    psychoeducation on emotional regulation and distraction strategy + Application

    Behavioral: psychoeducation on emotional regulation and distraction strategy + Application

  • Experimental
    experimental

    psychoeducation on emotional regulation and distraction strategy + Application with the FLOAT app

    Behavioral: psychoeducation on emotional regulation and distraction strategy · Device: Using the FLOAT app on a virtual reality device

Interventions

  • Behavioralpsychoeducation on emotional regulation and distraction strategy

    The experimenter gives the subject psychoeducation about emotional regulation and distraction strategy with the help of a conversation and a presentation.

  • DeviceUsing the FLOAT app on a virtual reality device

    The subject should wear the VR device, and use the FLOAT application.

  • Behavioralpsychoeducation on emotional regulation and distraction strategy + Application

    psychoeducation on emotional regulation and distraction strategy + Application

06

What researchers measure

Primary outcomes

  1. situational anxiety before session

    The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety

    Time frame: a week

  2. situational anxiety after session

    The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety

    Time frame: a week

  3. satisfaction with life

    Satisfaction with Life Scale (SWLS). 5 to 35. A high score represents higher life satisfaction and a lower score represents a lower life satisfaction

    Time frame: baseline

  4. satisfaction with life

    Satisfaction with Life Scale (SWLS). 5 to 35. A high score represents higher life satisfaction and a lower score represents a lower life satisfaction

    Time frame: week 3, after intervention

  5. Ease of using the technology

    System Usability Scale (SUS). scale from 0 to 100. A score higher than 70 indicates good usability, while a score lower than 50 indicates low usability.

    Time frame: week 3, after intervention

Secondary outcomes

  1. The FLOAT user experience

    A semi-structured interview, will be analyzed qualitatively

    Time frame: week 3, after intervention

07

Study locations

1 site
  • University of Haifa
    Haifa, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06197464
Lead sponsor
University of Haifa
Responsible party
Yael Enav (Dr. Yael Enav, University of Haifa) — Principal investigator
First posted
Jan 9, 2024
Start date
Mar 12, 2023
Primary completion
Apr 10, 2023
Completion
Jan 20, 2024
Last update
Apr 17, 2024

Study contacts

YAEL ENAV, professor
principal investigator · University of Haifa

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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