Effect of Virtual Reality on Depression in Adolescent Females

The purpose of this study is to investigate the effect of virtual reality on depression in adolescent females.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Device: Virtual reality headset; Drug: Selective serotonin reuptake inhibitors(SSRIs)

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug + virtual reality group; 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.	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
Active Comparator: Drug only group (controlled); 24 participants will receive antidepressant drugs Selective serotonin reuptake inhibitors(SSRIs) only	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Pharmacologic Actions; Chemical Actions and Uses; Selective Serotonin Reuptake Inhibitors
• Other Study ID Numbers: 012/006001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No