Efficacy of a Stepped Internet-based Program for Prevention and Early Intervention of Depression in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 947
- 试验地点
- 2
- 主要终点
- Depressive Symptoms
研究概览
简要总结
Background: Depression is prevalent and can have devastating effects on the life of adolescents. Computerized intervention programs for depression have shown positive results. There is less evidence in prevention and early treatment for depression in Latin American adolescents.
Purpose: The purpose of this study is to determine whether a stepped internet-based program is effective to prevent and early intervene depression in adolescents attending 9th to 11th grade in eight schools in Santiago, Chile.
Study design: A two-arm cluster-randomized clinical trial will be carried out with approximately 600 adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Attending from ninth grade to eleventh grade in the eight participating schools.
- •Informed consent and informed assent.
- •Score in the depression questionnaire PHQ-9 adolescent version between 5 and 14.
排除标准
- •High suicide risk defined by score in question 9 of the PHQ-9 adolescent version of 2 or more.
- •Current treatment with antidepressant drugs.
- •Current treatment with psychotherapy.
研究组 & 干预措施
Intervention group
The intervention consists of an Internet-based program. The program will last 3 months, with subsequent monthly reinforcement sessions for other 3 months.
The program is stepped, so that the more depressive symptomatology the more intensive program and consists of more components.
The students will interact with the program via a monitoring and feedback e-mail with 3 questions of the PHQ--9- adolescent version (1st, 2nd & 9th question) that they will receive every 2 weeks and a Website that will allow them to access to psycho-educational videos and information. There will also in the Website sections that will provide emergency information, the possibility of a contact via e-mail, and group chats. Adolescents with more depressive symptoms or suicidal risk will be invited to participate in an online counselling appointment or a face to face assessment with a mental health professional of the program.
干预措施: Take care of your mood (CUIDA TU ANIMO in Spanish) (Behavioral)
Control group
The comparison group will receive general psychoeducation of depression in adolescents and will be on the waiting list to receive the intervention in the event that its efficacy is demonstrated.
干预措施: Control (Other)
结局指标
主要结局
Depressive Symptoms
时间窗: 6 months after baseline assessment
Patient Health Questionnaire-9 (PHQ-9) adolescent version, total score varies between 0 and 27, higher values represent a worse outcome
次要结局
- Health-Related Quality of Life Index(6 and 12 months after baseline assessment)
- Depressive Symptoms(12 months after baseline assessment)
- Anxiety Symptoms(6 and 12 months after baseline assessment)
- Social Problem Solving Skills(6 and 12 months after baseline assessment)
- Dysfunctional Thoughts(6 and 12 months after baseline assessment)
- Emotion Regulation(6 and 12 months after baseline assessment)
- Depression Stigma(6 and 12 months after baseline assessment)
研究者
Vania Martínez-Nahuel
Principal Investigator
University of Chile