Effectiveness of the Group Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al. 2011, 2019a, 2019b) in Adults in a Public Mental Health Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Anxiety Symptoms
研究概览
简要总结
This study has three primary objectives:
- To adapt the Spanish version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011, 2019a, 2019b) for delivery in a group format within the Spanish Public Mental Health System for adults diagnosed with emotional disorders.
- To evaluate the effectiveness of the intervention.
- To assess its clinical feasibility and acceptability in routine clinical practice.
Outcomes will include anxiety, depression, somatic symptoms, transdiagnostic variables, functional impairment, quality of life, and participant satisfaction. These outcomes will be assessed at baseline, post-treatment, and 3-month follow-up.
The intervention is expected to improve emotional symptoms, functional impairment, and quality of life. In addition, the study will explore whether this group-based transdiagnostic approach may help lower demand on public mental health services.
详细描述
Anxiety and depressive disorders are among the leading causes of disability and contributors to the global burden of disease worldwide. To address this public health challenge, stepped-care models have been developed to organize treatment according to patients' clinical needs and progression. Within this framework, the transdiagnostic approach proposes that emotional disorders share common underlying transdiagnostic mechanisms, including elevated negative affect and maladaptive emotion regulation strategies such as emotional avoidance.
Accordingly, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) has emerged as an evidence-based intervention for anxiety, depressive, and related emotional disorders. The UP aims to enhance adaptive emotion regulation and lower maladaptive behavioral avoidance, thereby promoting improvements across a broad range of emotional symptoms.
This study aims to adapt and implement the Spanish version of the UP in a group format for adults diagnosed with an emotional disorder receiving treatment within the Spanish Public Mental Health System. In addition, the study will evaluate the intervention's effectiveness, feasibility, acceptability, and cost-effectiveness. The intervention will be delivered in Public Mental Health Units of the La Rioja Health Service.
Adults aged 18 to 65 years diagnosed with an emotional disorder will be recruited. The study will employ a randomized controlled trial design with two parallel groups: a Treatment as Usual (TAU) group and an experimental group (UP + TAU). Assessments will be conducted at pre-treatment, post-treatment, and 3-month follow-up. Outcome measures will assess anxiety, depression, somatic symptoms, transdiagnostic processes, functional impairment, quality of life, participant satisfaction, and intervention cost-effectiveness.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years.
- •Ability and willingness to provide written informed consent.
- •Sufficient proficiency in Spanish to participate in the intervention and complete study assessments.
- •Sufficient cognitive capacity to understand the intervention content.
- •A primary diagnosis of an emotional disorder with mild, moderate, or severe symptom severity, including Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive and Related Disorders, Trauma and Stressor-Related Disorders, Dissociative Disorders and Somatic Symptom and Related Disorders.
- •Presence of emotional symptoms (e.g., anxiety, depressive, or phobic symptoms), somatic symptoms, obsessive symptoms, and/or avoidance behaviors associated with clinically significant impairment, as indicated by moderate or higher scores on the GAD-7, PHQ-9, and/or PHQ-15.
排除标准
- •Refusal to provide informed consent or withdrawal of consent during the study.
- •Current severe substance use disorder or behavioral addiction.
- •Current high suicide risk.
- •Current psychotic symptoms or psychotic disorder.
- •Neurological disorders or severe medical conditions that could interfere with participation in or adherence to the intervention.
- •Intellectual disability, significant language difficulties, or any other condition that may impair the participant's ability to understand the intervention content.
研究组 & 干预措施
3-month Treatment as Usual
Participants assigned to the control group will receive treatment as usual (TAU) provided by the collaborating Public Mental Health Units. TAU will be delivered individually by the participant's assigned mental health professional and may include psychological and/or pharmacological treatment according to routine clinical practice.
干预措施: TAU (Behavioral)
结局指标
主要结局
Anxiety Symptoms
时间窗: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006). The GAD-7 consists of seven items with total scores ranging from 0 to 21, where higher scores indicate greater anxiety symptom severity.
Depressive Symptoms
时间窗: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The PHQ-9 includes nine items with total scores ranging from 0 to 27, where higher scores indicate greater depressive symptom severity.
Somatic Symptoms
时间窗: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Patient Health Questionnaire-15 (PHQ-15; Kroenke et al., 2010). The PHQ-15 consists of fifteen items with total scores ranging from 0 to 30, where higher scores indicate greater somatic symptom severity.
次要结局
- Experiential avoidance(Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.)
- Functional impairment(Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.)
- Perceived quality of life(Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.)
- Transdiagnostic dimensions(Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.)
- Satisfaction with the program(Immediately after completion of the 3-month intervention.)
- Use of healthcare resources(Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.)
研究者
Patricia Fernández Couto
Clinical Psychology Specialist
University of La Rioja