DepressionNCT07452341
Effect of Virtual Reality on Depression in Adolescent Females
A study testing Virtual reality headset and Selective serotonin reuptake inhibitors(SSRIs) in people with Depression, run by Cairo University.
Trial summary
The purpose of this study is to investigate the effect of virtual reality on depression in adolescent females. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Virtual reality headset and Selective serotonin reuptake inhibitors(SSRIs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
The purpose of this study is to investigate the effect of virtual reality on depression in adolescent females.
Read the detailed description
Depression is most commonly found in adolescents and large percentage of them don't receive management.
People with depression usually experience at least five of the following 9 characteristics: (1) people feel sad and unhappy; (2) have less interest in doing things; (3) individuals do not follow a diet, but their weight losses are obvious; (4) their appetites change and their weight may increase; (5) they suffer insomnia or drowsiness; (6) some people have mental agitation; (7) they feel that life is meaningless, or they feel guilty; (8) they have difficulty concentrating; or (9) they have suicidal thoughts . Individuals who develop depression may have experienced an anxiety disorder earlier in life.
Depression is most commonly found in adolescents and large percentage of them don't receive management The application of emerging technology in health promotion has generated substantial public interest. Among the emerging technologies that may potentially aid in the treatment of depression, virtual reality (VR) is the most exciting and technologically-advanced.
A virtual environment provides a greater degree of control for the therapists to customize, reproduce, and tweak several treatment parameters according to the patient's needs.
- Conditions
- Depression
- Being tested
- Virtual reality headset, Selective serotonin reuptake inhibitors(SSRIs)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
Participants will use virtual reality glasses during treatment sessions for approximately 30 minutes per session, once per week for 8 weeks .
Selective serotonin reuptake inhibitors(SSRIs)Drug
All adolescent females in the control group will receive antidepressant drugs Selective serotonin reuptake inhibitors(SSRIs) for 8 weeks as described by the psychiatrist
| Study group | Role | What they receive |
|---|---|---|
| Drug + virtual reality group | Experimental | 24 Participants in this group will receive the same standard drug therapy(Selective serotonin reuptake inhibitors(SSRIs) in addition to virtual reality exposure using VR headset during the treatment sessions. Receives: Device: Virtual reality headset; Drug: Selective serotonin reuptake inhibitors(SSRIs) |
| Drug only group (controlled) | Active comparator | 24 participants will receive antidepressant drugs Selective serotonin reuptake inhibitors(SSRIs) only Receives: Drug: Selective serotonin reuptake inhibitors(SSRIs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression.
Beck depression scale assess depression levels in both groups (A\&B) before and after the end of the study. It is a self-administered questionnaire containing 21 items which takes about five minutes to be complete.
Patients will be asked to complete the questionnaire, add up the score for each of the twenty-one questions by counting the number to the right of each question she marked. The highest possible total for the whole test is sixty-three this mean patient circled number three on all twenty-one questions, the lowest possible score for each question is zero, this mean she circled zero on each question
Measured: 8 weeks
2-Calculation the score of KIDSCREEN-52 questionnaire to assess the quality of life
KIDSCREEN-52 questionnairet consists of 52 itemes that can measure the following 10 dimensions: Physical Well-Being (5 items), Psychological Well-Being (6 items), Moods and Emotions (7 items),Self-Perception (5 items), Autonomy (5 items),Parent Relations and Home Life (6 items), Financial Resources (3 items), Peers and Social Support (6 items),School Environment (6 items) and social acceptance( Bullying) (3 items). It has high validity and reliability. Patients will be asked to complete the questionnaire,scores are computed for each dimension and are transformed into T-values with a mean of 50 and a standard deviation of 10; a low score indicates a poor QOL and higher score indicates higher QOL and wellbeing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed Abdelhaleem Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452341
- Sponsor's protocol ID
- 012/006001
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Depression in Adolescent Females
- ClinicalTrials.gov ID
- NCT07452341
- Acronym / sponsor ID
- 012/006001
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 5 Mar 2026 (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 purpose of this study is to investigate the effect of virtual reality on depression in adolescent females.
Detailed description
Depression is most commonly found in adolescents and large percentage of them don't receive management.
People with depression usually experience at least five of the following 9 characteristics: (1) people feel sad and unhappy; (2) have less interest in doing things; (3) individuals do not follow a diet, but their weight losses are obvious; (4) their appetites change and their weight may increase; (5) they suffer insomnia or drowsiness; (6) some people have mental agitation; (7) they feel that life is meaningless, or they feel guilty; (8) they have difficulty concentrating; or (9) they have suicidal thoughts . Individuals who develop depression may have experienced an anxiety disorder earlier in life.
Depression is most commonly found in adolescents and large percentage of them don't receive management The application of emerging technology in health promotion has generated substantial public interest. Among the emerging technologies that may potentially aid in the treatment of depression, virtual reality (VR) is the most exciting and technologically-advanced.
A virtual environment provides a greater degree of control for the therapists to customize, reproduce, and tweak several treatment parameters according to the patient's needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug + virtual reality group | Experimental | Device: Virtual reality headset, Drug: Selective serotonin reuptake inhibitors(SSRIs)24 Participants in this group will receive the same standard drug therapy(Selective serotonin reuptake inhibitors(SSRIs) in addition to virtual reality exposure using VR headset during the treatment sessions. |
| Drug only group (controlled) | Active comparator | Drug: Selective serotonin reuptake inhibitors(SSRIs)24 participants will receive antidepressant drugs Selective serotonin reuptake inhibitors(SSRIs) only |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Virtual reality headsetParticipants will use virtual reality glasses during treatment sessions for approximately 30 minutes per session, once per week for 8 weeks . | Device | Drug + virtual reality group |
| 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 | Drug | Drug + virtual reality group, Drug only group (controlled) |
Primary outcome
1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression.
Time frame: 8 weeks
Beck depression scale assess depression levels in both groups (A\&B) before and after the end of the study. It is a self-administered questionnaire containing 21 items which takes about five minutes to be complete. Patients will be asked to complete the questionnaire, add up the score for each of the twenty-one questions by counting the number to the right of each question she marked. The highest possible total for the whole test is sixty-three this mean patient circled number three on all twenty-one questions, the lowest possible score for each question is zero, this mean she circled zero on each question
2-Calculation the score of KIDSCREEN-52 questionnaire to assess the quality of life
Time frame: 8 weeks
KIDSCREEN-52 questionnairet consists of 52 itemes that can measure the following 10 dimensions: Physical Well-Being (5 items), Psychological Well-Being (6 items), Moods and Emotions (7 items),Self-Perception (5 items), Autonomy (5 items),Parent Relations and Home Life (6 items), Financial Resources (3 items), Peers and Social Support (6 items),School Environment (6 items) and social acceptance( Bullying) (3 items). It has high validity and reliability. Patients will be asked to complete the questionnaire,scores are computed for each dimension and are transformed into T-values with a mean of 50 and a standard deviation of 10; a low score indicates a poor QOL and higher score indicates higher QOL and wellbeing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset and Selective serotonin reuptake inhibitors(SSRIs) in people with Depression, run by Cairo University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression. (time frame: 8 weeks). The study lists 2 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 11 Mar 2026.