Effect of Virtual Reality on Depression in Adolescent Females
Virtual Reality for Teen Girls with Depression
Plain English Summary
Effect of Virtual Reality on Depression in Adolescent Females is a Not Applicable clinical trial sponsored by Cairo University studying Depression. This study tests if virtual reality (VR) can help teenage girls with depression. It's for females aged 13-18 diagnosed with mild to moderate depression. Participants will use VR headsets for 30 minutes weekly for 8 weeks, or receive standard medication. Alternatives include standard antidepressant medication and psychotherapy. The trial aims to enroll 48 participants.
Official Summary
The purpose of this study is to investigate the effect of virtual reality on depression in adolescent females.
Who Can Participate
Here is what you need to know about eligibility for this trial. Girls aged 13-18 diagnosed with depression by a psychiatrist. Must have a Beck Depression Inventory score between 11-30 (mild to moderate). Must be interested in using VR for mental health. Cannot have other major illnesses, severe mental illness, or be receiving other psychotherapy. This trial is studying Depression, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure changes in depression symptoms using the Beck Depression Inventory, indicating how much VR helps reduce feelings of sadness and hopelessness. The specific primary outcome measures are: 1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression. (8 weeks); 2-Calculation the score of KIDSCREEN-52 questionnaire to assess the quality of life (8 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a gap in mental health treatment by exploring innovative VR technology for adolescent depression, a growing concern. This research targets Depression, where improved treatment options are needed.
Investor Insight
This trial signals interest in novel digital therapeutics for a large adolescent mental health market, with potential for early adoption if successful.
Is This Trial Right for Me?
Ask your doctor if VR therapy is right for you and how it compares to other treatments. Participation involves weekly 30-minute VR sessions for 8 weeks, with regular check-ins. You'll complete questionnaires about your mood and quality of life. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 48 participants
Interventions
- DEVICE: Virtual reality headset — Participants will use virtual reality glasses during treatment sessions for approximately 30 minutes per session, once per week for 8 weeks .
- DRUG: Selective serotonin reuptake inhibitors(SSRIs) — All adolescent females in the control group will receive antidepressant drugs Selective serotonin reuptake inhibitors(SSRIs) for 8 weeks as described by the psychiatrist
Primary Outcomes
- 1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression. (8 weeks)
- 2-Calculation the score of KIDSCREEN-52 questionnaire to assess the quality of life (8 weeks)
Full Eligibility Criteria
Inclusion Criteria: * Adolescent females suffer from depression who are diagnosed and referred by the psychiatrist. * Their ages will range from 13-18 years old * Their BMI will range from 15.5 -24.9 kg/m2 * They are interested in their mental state or with depressive disorders and their score on Beck depression inventory (BDI) between 11-30 (mild to moderate depression) * They are interested in using VR technology to improve mental health problems. Exclusion Criteria: * Patients who suffer from major diseases other than depression. * Adolescents who are not interested in VR. * Patients with severe mental illness or repetitive suicidal trials . * Patients who receive any other psychotherapy. * Obese patients with BMI more than 26.2 -29.5kg/m2
Frequently Asked Questions
What is clinical trial NCT07452341?
NCT07452341 is a Not Applicable INTERVENTIONAL study titled "Effect of Virtual Reality on Depression in Adolescent Females." It is currently not yet recruiting and is sponsored by Cairo University. The trial targets enrollment of 48 participants.
What conditions does NCT07452341 study?
This trial investigates treatments for Depression. The primary condition under study is Depression.
What treatments are being tested in NCT07452341?
The interventions being studied include: Virtual reality headset (DEVICE), Selective serotonin reuptake inhibitors(SSRIs) (DRUG). Participants will use virtual reality glasses during treatment sessions for approximately 30 minutes per session, once per week for 8 weeks .
What does Not Applicable mean for NCT07452341?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07452341?
This trial is currently "Not Yet Recruiting." It started on 2026-08-01. The estimated completion date is 2027-02-01.
Who is sponsoring NCT07452341?
NCT07452341 is sponsored by Cairo University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07452341?
The trial aims to enroll 48 participants. The trial has not yet started recruiting.
How is NCT07452341 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07452341?
The primary outcome measures are: 1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression. (8 weeks); 2-Calculation the score of KIDSCREEN-52 questionnaire to assess the quality of life (8 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07452341?
The official record for NCT07452341 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07452341. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07452341 testing in simple terms?
This study tests if virtual reality (VR) can help teenage girls with depression. It's for females aged 13-18 diagnosed with mild to moderate depression.
Why is this trial significant?
This trial addresses a gap in mental health treatment by exploring innovative VR technology for adolescent depression, a growing concern.
What are the potential risks of participating in NCT07452341?
Potential side effects of VR include eye strain, dizziness, or nausea. VR may not be effective for everyone, and standard treatments will still be available. There's a risk of worsening depression if the treatment is not effective. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07452341?
Ask your doctor if VR therapy is right for you and how it compares to other treatments. Participation involves weekly 30-minute VR sessions for 8 weeks, with regular check-ins. You'll complete questionnaires about your mood and quality of life. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07452341 signal from an investment perspective?
This trial signals interest in novel digital therapeutics for a large adolescent mental health market, with potential for early adoption if successful. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will use VR headsets for 30 minutes weekly for 8 weeks, or receive standard medication. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.