Effect of Virtual Reality on Depression in Adolescent Females

NCT07452341 | Not Yet Recruiting

• 1 other identifier: 012/006001
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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

Drug: Selective serotonin reuptake inhibitors(SSRIs)

Interventions

Virtual reality headset DEVICE

Participants will use virtual reality glasses during treatment sessions for approximately 30 minutes per session, once per week for 8 weeks .

Drug + virtual reality group

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

Drug + virtual reality group; Drug only group (controlled)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: Adolescent females are eligible to participate
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Depression

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03