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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06197464
Other study ID # YAEL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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