Telepsychiatry-Based Collaborative Program to Improve the Management of Adolescent Depression in Primary Care Clinics in the Araucanía Region, Chile: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 143
- 试验地点
- 7
- 主要终点
- Change from baseline in Beck Depression Inventory (BDI)
研究概览
简要总结
Background: Depression is common in adolescents and it is associated with serious consequences. In Chile, primary care team has a leading role in the management of depression in adolescents. Nevertheless, the majority of primary care professionals report not feeling adequately prepared to take on this responsibility and having difficulties referring patients to specialists. This situation is particularity complex in regions far away from the central zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical expertise.
Purpose: The purpose of this study is to determine whether a telepsychiatry-based collaborative program is effective to improve the management of depression in adolescents between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.
Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents. The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program will be evaluated.
详细描述
General aim To carry out a randomized controlled trial to compare the efficacy of telepsychiatry intervention versus usual care to treat depression in adolescents in primary care clinics in the Araucanía Region, Chile.
Specific aims
- To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
- To compare the level of health-related quality of life (HRQoL) of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
- To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics.
- To evaluate adolescents' satisfaction with a telepsychiatry program.
- To evaluate health staff's satisfaction with a telepsychiatry program.
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 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets diagnostic criteria of a depressive disorder according a structured interview (MINI-KID)
排除标准
- •Psychotic symptoms
- •Bipolar disorder
- •Current substance and/or alcohol dependence
- •Suicide risk that requires specialized treatment
- •Current treatment with antidepressant and/or psychotherapy
- •Low intellectual abilities
结局指标
主要结局
Change from baseline in Beck Depression Inventory (BDI)
时间窗: Baseline and 12 weeks
次要结局
- Change from baseline in KIDSCREEN-27(Baseline and 12 weeks)
研究者
Vania Martínez-Nahuel
Dr.med.
University of Chile