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

FLOAT Through Anxiety: Examining the Efficacy and Safety of the Virtual Reality Application "Float" as a Tool to Distract From Negative Emotions and Thoughts in People With High Levels of Anxiety and Stress

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

Study Overview

• Status: Completed
• Conditions: Experimental; Control
• Intervention / Treatment: Behavioral: psychoeducation on emotional regulation and distraction strategy + Application; Behavioral: psychoeducation on emotional regulation and distraction strategy; Device: Using the FLOAT app on a virtual reality device

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • University of Haifa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; psychoeducation on emotional regulation and distraction strategy + Application	Behavioral: psychoeducation on emotional regulation and distraction strategy + Application; 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; The experimenter gives the subject psychoeducation about emotional regulation and distraction strategy with the help of a conversation and a presentation.; Device: Using the FLOAT app on a virtual reality device; The subject should wear the VR device, and use the FLOAT application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
situational anxiety before session	The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety	a week
situational anxiety after session	The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety	a week
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	baseline
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	week 3, after intervention
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.	week 3, after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The FLOAT user experience	A semi-structured interview, will be analyzed qualitatively	week 3, after intervention

Collaborators and Investigators

• Sponsor: University of Haifa
• Investigators: Principal Investigator: YAEL ENAV, professor, University of Haifa

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2023
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: YAEL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No