Efficacy of the Unified Protocol for Transdiagnostic Treatment for Adolescents With Symptoms of Anxiety and Depression: a School-based Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Anxiety symptoms
研究概览
简要总结
The main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment.
详细描述
Emotional problems, such as anxiety and depression, are among the leading causes of associated disability and burden of disease worldwide among young people. Therefore, it is necessary to address this emerging social challenge through the implementation of prevention strategies in relevant stages of development such as adolescence. In recent years, a transdiagnosis approach to emotional disorders has been promoted, highlighting the unified protocol for transdiagnostic treatment of emotional disorders and symptoms in its different versions (adulthood, adolescence, and childhood). In this context, the main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment. Adolescents aged 12-18 at high risk of for anxiety and depression disorders (cut-off scores 10-15 points, PHQ-9 and GAD-7) are selected. The design is a randomized controlled trial with two groups: active control (relaxation) and experimental (UP-A). Pre-test, post-test, and follow-up at 6, 12 and 18 months will be carried out. The impact of different behavioural, cognitive, affective, social, and academic functioning indicators is analyzed, as well as their effects in the short, medium, and long term. The satisfaction of the program by users (students, parents, and professionals) will also be evaluated. The implementation and validation of manualized and empirically validated psychological intervention programs, such as UP-A, should be a priority in educational and socio-health policies.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 12-18 years old
- •Written informed consent from adolescent and legal guardian
- •Being able to understand and read Spanish.
- •Moderate depressive and anxiety symptoms according to the screening (score moderate level in the PHQ-9 and GAD-7).
排除标准
- •Being diagnosed a mental disorder or alcohol and/or substance dependence disorder.
- •The presence of high suicidal risk
- •A medical disease or condition which prevent the participant from carry out the psychological treatment.
- •Receiving another psychological treatment while the study is still ongoing.
- •The increase and/or changes in the medication of participants receiving pharmacological treatment during the study
结局指标
主要结局
Anxiety symptoms
时间窗: Baseline to 18 months after start of interventions
Change in the Generalised Anxiety Disorder Assessment (GAD-7) total score. GAD-7 total score for the seven items ranges from 0 to 21.Higher scores mean a worse outcome.
Depression symptoms
时间窗: Baseline to 18 months after start of interventions
Change in the Patient Health Questionnaire-9 (PHQ-9) total score. PHQ-9 total score for the nine items ranges from 0 to 27.Higher scores mean a worse outcome.
次要结局
- Educational achievement outcome(Baseline to 18 months after start of interventions)
- Transdiagnostic dimensions(Baseline to 18 months after start of interventions)
- Health-related quality of life(Baseline to 18 months after start of interventions)
- Positive and Negative Affect(Baseline to 18 months after start of interventions)
- Emotional and behavioural problems(Baseline to 18 months after start of interventions)
研究者
Eduardo Fonseca Pedrero
Director
University of La Rioja