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

Not Applicable

Completed

• Conditions: Control; Experimental
• Interventions: 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

• Registration Number: NCT06197464
• Lead Sponsor: University of Haifa

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-12
• Primary Completion: 2023-04-10
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-09
• Study Completion: 2024-01-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
control	psychoeducation on emotional regulation and distraction strategy + Application	psychoeducation on emotional regulation and distraction strategy + Application
experimental	Using the FLOAT app on a virtual reality device	psychoeducation on emotional regulation and distraction strategy + Application with the FLOAT app
experimental	psychoeducation on emotional regulation and distraction strategy	psychoeducation on emotional regulation and distraction strategy + Application with the FLOAT app

Primary Outcome Measures

Name	Time	Method
situational anxiety before session	a week	The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety
situational anxiety after session	a week	The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety
Ease of using the technology	week 3, after intervention	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.
satisfaction with life	week 3, after intervention	Satisfaction with Life Scale (SWLS). 5 to 35. A high score represents higher life satisfaction and a lower score represents a lower life satisfaction

Secondary Outcome Measures

Name	Time	Method
The FLOAT user experience	week 3, after intervention	A semi-structured interview, will be analyzed qualitatively

Trial Locations

Locations (1)

University of Haifa; 🇮🇱 Haifa, Israel