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

Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06197464
• Other study ID #: YAEL
• Status: Completed
• Phase: N/A
• Start date: March 12, 2023
• Est. completion date: January 20, 2024

Study information

• Verified date: April 2024
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 20, 2024
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Control
• Experimental

Intervention

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.

Behavioral:
• psychoeducation on emotional regulation and distraction strategy + Application
psychoeducation on emotional regulation and distraction strategy + Application

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The FLOAT user experience	A semi-structured interview, will be analyzed qualitatively	week 3, after intervention