Effect of Virtual Reality on Depression in Adolescent Females
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- 1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression.
研究概览
简要总结
The purpose of this study is to investigate the effect of virtual reality on depression in adolescent females.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Virtual reality headset (Device)
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.
干预措施: Selective serotonin reuptake inhibitors(SSRIs) (Drug)
Drug only group (controlled)
24 participants will receive antidepressant drugs Selective serotonin reuptake inhibitors(SSRIs) only
干预措施: Selective serotonin reuptake inhibitors(SSRIs) (Drug)
结局指标
主要结局
1-Calculation the score of Beck Depression Inventory [BDI] to assess the severity of depression.
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Heba Mohamed Abdelhaleem Hassan
Principal investigator
Cairo University