Implementation, Effficacy and Cost-effective Study of the Unified Protocol in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Overall Anxiety Severity and Impairment Scale (OASIS)
研究概览
简要总结
The present randomized, controlled trial will compare the efficacy, cost-effectiveness, and implementation characteristics of a blended intervention based on the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders against the treatment as usual in a sample of patients with emotional disorders in the Spanish National Health System.
详细描述
Emotional disorders (EDs;including anxiety disorders, unipolar mood disorders, and related disorders) are the most prevalent mental disorders in the general population. In Spain, anxiety disorders and mood disorders affect approximately two million (4.1%) and two and half million (5.2%) individuals, respectively. As a result of their prevalence in the society, EDs have become an alarming health problem due to their associate costs. These disorders have a direct cost of 22.000 million euros (500 euros per capita and year). The total expense of these disorders entails 2.2% of the Gross Domestic Product in Spain. Due to the excessive demand for treatment, mental health services of our National Health System (NHS) are collapsed with large waiting lists, which results in a great difficulty to dedicate the recommended time to attend patients who require psychological treatment. Therefore, it is needed to find solutions for the effective and cost-effective treatment of EDs in our NHS. In the last years, several solutions have been proposed to alleviate this important health problem.
The general objective of this project is to contribute to the dissemination of evidence-based psychological treatments in our Public National Health System for the most prevalent mental disorders in our society, emotional disorders (EDs). The investigators will study the efficacy, cost-effectiveness, and implementation characteristics (acceptability, usability, and utility) of a blended intervention which will enhance face-to-face treatment by incorporating an app-based intervention onsite treatment. Based on the most recent clinical advances in the treatment of EDs, the investigators will use the Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP). The investigators hypothesize that the blended intervention will be superior to the treatment as usual (face-to-face, specific-disorder treatment) because patients in the UP-APP condition will continue working with the app at home between sessions. In sum, this project is composed of three connected studies: a validation study in a clinical sample of patients with EDs, two pilot studies to help develop the app based on the UP principles, and a multicenter, randomized and controlled clinical trial that will be conducted by 12 clinical psychologist working in 8 different provinces in Spain.
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 (Participant)
盲法说明
Patients (participants) will know the treatment they have been assigned to, but they will not know whether that treatment is considered TAU or experimental (UP-APP). Healthcare professionals and researchers will know the condition each patient has been assigned to (mandatory to provide a given type of intervention).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Principal diagnosis of Emotional disorder (Evaluated by MINI interview)
- •The patient is over 18 years of age
- •The patient is fluent in the language in which the therapy is performed (Spanish in the present study)
- •To have a Smartphone
- •Patients taking pharmacological treatment for their ED will be asked to maintain the same dosages and medications for at least 3 months prior to enrolling in the study and during the whole treatment
- •The patient signs the informed consent form.
排除标准
- •The patient presents a severe condition that would require to be prioritized for treatment, these include a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months
- •The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable Cognitive behavioral therapy (CBT) principles within the past 5 years.
结局指标
主要结局
Overall Anxiety Severity and Impairment Scale (OASIS)
时间窗: Up to 12 months
The scale presents five items. These items are related with the frequency and intensity of anxiety symptoms and their interference with the person's work or school life and with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety).
Overall Depression Severity and Impairment Scale (ODSIS)
时间窗: Up to 12 months
Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4.
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
时间窗: Enrolment and Up to 12 months
Diagnostic interview
次要结局
- The Multidimensional Emotional Disorder Inventory (MEDI)(Up to 12 months)
- Emotion Regulation Questionnaire (ERQ)(Up to 12 months)
- Health-related quality of life (EuroQol-5D)(Up to 12 months)
- Adaptation of Client Satisfaction Questionnaire [CSQ-8](Up to 12 months)
- Five Facet Mindfulness Questionnaire (FFMQ)(Up to 12 months)
- Difficulties in Emotion Regulation Scale (DERS)(Up to 12 months)
- Credibility/Expectancy Questionnaire (CEQ)(Up to 12 months)
- Client Service Receipt Inventory (CSRI)(Up to 12 months)
- Working Alliance Inventory-Short (WAI-S)(During psychological treatment)
- Evaluation questionnaire of the Unified Protocol (UP) modules(Up to 12 months)
- System Usability Scale (SUS)(Up to 12 months)
- Quality-adjusted Life Years (QALYs)(Up to 12 months)
- UP-APP outcomes(During psychological treatment)
- Evaluation of the UP-APP(Up to 12 months)