NCT06197464

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. 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. 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

29 days

First QC Date

June 13, 2023

Last Update Submit

April 16, 2024

Conditions

ControlExperimental

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • The FLOAT user experience

    week 3, after intervention

Study Arms (2)

control

ACTIVE COMPARATOR

psychoeducation on emotional regulation and distraction strategy + Application

Behavioral: 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 strategyDevice: Using the FLOAT app on a virtual reality device

Interventions

psychoeducation on emotional regulation and distraction strategyBEHAVIORAL

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

experimental
Using the FLOAT app on a virtual reality deviceDEVICE

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

experimental
psychoeducation on emotional regulation and distraction strategy + ApplicationBEHAVIORAL

psychoeducation on emotional regulation and distraction strategy + Application

control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, Israel

Location

Study Officials

  • YAEL ENAV, professor

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Yael Enav

Study Record Dates

First Submitted

June 13, 2023

First Posted

January 9, 2024

Study Start

March 12, 2023

Primary Completion

April 10, 2023

Study Completion

January 20, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

IL(1)