Skip to main content
OpenTrials
Completed

NCT Number: NCT06197464

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Control Experimental

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Haifa

Haifa, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

psychoeducation on emotional regulation and distraction strategy

Behavioral

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

Using the FLOAT app on a virtual reality device

Device

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

psychoeducation on emotional regulation and distraction strategy + Application

Behavioral

psychoeducation on emotional regulation and distraction strategy + Application

Primary outcomes

  1. situational anxiety before session

    Time frame: a week

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

  2. situational anxiety after session

    Time frame: a week

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

  3. satisfaction with life

    Time frame: baseline

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

  4. satisfaction with life

    Time frame: 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

  5. Ease of using the technology

    Time frame: 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.

Secondary outcomes

  1. The FLOAT user experience

    Time frame: week 3, after intervention

    A semi-structured interview, will be analyzed qualitatively

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 9, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.