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

NCT ID: NCT06197464

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-12
• Study Completion Date: 2024-01-20

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

Conditions

Control; Experimental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control

psychoeducation on emotional regulation and distraction strategy + Application

Group Type: ACTIVE_COMPARATOR

psychoeducation on emotional regulation and distraction strategy + Application

Intervention Type: BEHAVIORAL

psychoeducation on emotional regulation and distraction strategy + Application

experimental

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

Group Type: EXPERIMENTAL

psychoeducation on emotional regulation and distraction strategy

Intervention Type: 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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: BEHAVIORAL

Using the FLOAT app on a virtual reality device

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

Intervention Type: DEVICE

psychoeducation on emotional regulation and distraction strategy + Application

psychoeducation on emotional regulation and distraction strategy + Application

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Yael Enav

Dr. Yael Enav

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YAEL ENAV, professor

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

Locations

University of Haifa

Haifa, , Israel

Countries

Israel

Other Identifiers

YAEL

Identifier Type: -

Identifier Source: org_study_id