ControlNCT06197464
FLOAT Through Anxiety: Virtual Reality Application's Efficacy as a Tool to Distract From Negative Emotions and Thoughts
A study testing psychoeducation on emotional regulation and distraction strategy, Using the FLOAT app on a virtual reality device and psychoeducation on emotional regulation and distraction strategy + Application in people with Control and Experimental, run by University of Haifa at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Control, Experimental
- What is being tested?
- psychoeducation on emotional regulation and distraction strategy, Using the FLOAT app on a virtual reality device and psychoeducation on emotional regulation and distraction strategy + Application
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Mar 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 'moderate' or 'severe' levels of stress and/or anxiety according to the DASS-21 questionnaire
- student
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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:
- 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?
- Will subjects who are used to using technology find greater comfort in using VR compared to subjects who are not used to it?
- 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
- Being tested
- psychoeducation on emotional regulation and distraction strategy, Using the FLOAT app on a virtual reality device, psychoeducation on emotional regulation and distraction strategy + Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducation on emotional regulation and distraction strategyBehavioural
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 deviceDevice
The subject should wear the VR device, and use the FLOAT application.
psychoeducation on emotional regulation and distraction strategy + ApplicationBehavioural
psychoeducation on emotional regulation and distraction strategy + Application
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | psychoeducation on emotional regulation and distraction strategy + Application Receives: Behavioral: psychoeducation on emotional regulation and distraction strategy + Application |
| experimental | Experimental | psychoeducation on emotional regulation and distraction strategy + Application with the FLOAT app Receives: Behavioral: psychoeducation on emotional regulation and distraction strategy; Device: Using the FLOAT app on a virtual reality device |
What is being measured
The primary outcome is the main question the study is designed to answer.
situational anxiety before session
The State-Trait Anxiety Inventory (STAI) questionnaire. range 20 to 100, with a higher score representing higher levels of anxiety
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: week 3, after intervention
Secondary outcomes (1)
The FLOAT user experience
A semi-structured interview, will be analyzed qualitatively
Measured: week 3, after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start12 Mar 2023
- Primary completion10 Apr 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Enav, University of Haifa
- Investigators
- YAEL ENAV, professor, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197464
- Sponsor's protocol ID
- YAEL
- Status last verified
- Apr 2024
- First submitted
- 13 Jun 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06197464
- Acronym / sponsor ID
- YAEL
- Conditions
- Control, Experimental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Will subjects who are used to using technology find greater comfort in using VR compared to subjects who are not used to it?
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Behavioral: psychoeducation on emotional regulation and distraction strategy + Applicationpsychoeducation on emotional regulation and distraction strategy + Application |
| experimental | Experimental | Behavioral: psychoeducation on emotional regulation and distraction strategy, Device: Using the FLOAT app on a virtual reality devicepsychoeducation on emotional regulation and distraction strategy + Application with the FLOAT app |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 'moderate' or 'severe' levels of stress and/or anxiety according to the DASS-21 questionnaire
- student
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychoeducation on emotional regulation and distraction strategyThe experimenter gives the subject psychoeducation about emotional regulation and distraction strategy with the help of a conversation and a presentation. | Behavioural | experimental |
| Using the FLOAT app on a virtual reality deviceThe subject should wear the VR device, and use the FLOAT application. | Device | experimental |
| psychoeducation on emotional regulation and distraction strategy + Applicationpsychoeducation on emotional regulation and distraction strategy + Application | Behavioural | control |
Primary outcome
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
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
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
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
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.
1 secondary outcome
The FLOAT user experience
Time frame: week 3, after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YAEL ENAV, professor principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation on emotional regulation and distraction strategy, Using the FLOAT app on a virtual reality device and psychoeducation on emotional regulation and distraction strategy + Application in people with Control and Experimental, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
situational anxiety before session (time frame: a week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.