ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), Depressive Disorder, Emotional Disorders, Somatic Disorders
Conditions
Keywords
Unified Protocol, emotional disorder, UP, treatment
Brief summary
This study has three primary objectives: 1. 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. 2. To evaluate the effectiveness of the intervention. 3. 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.
Detailed description
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.
Interventions
BEHAVIORALUP
The UP includes eight modules designed to enhance emotion regulation skills: (1) Motivation Enhancement and Goal Setting; (2) Psychoeducation and Tracking Emotional Experiences; (3) Training in Present-Focused Emotional Awareness; (4) Cognitive Flexibility; (5) Countering Emotional Behaviors; (6) Understanding and Tolerating Physical Sensations; (7) Emotional Exposure; and (8) Recognizing Achievements and Maintaining Progress.
BEHAVIORALTAU
TAU in the Public Mental Health Units of the La Rioja Health Service consists of care provided by specialists in Clinical Psychology and/or Psychiatry in accordance with routine clinical practice.
Sponsors
Patricia Fernández Couto
University of La Rioja
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experiential avoidance | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. | Change in total score on the Acceptance and Action Questionnaire-II (AAQ-II; Ruiz et al., 2013). The AAQ-II includes seven items with total scores ranging from 7 to 42, where higher scores reflect greater experiential avoidance. |
| Functional impairment | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. | Change in total score on the Inadaptation Scale (EI; Echeburúa et al., 2000). The EI consists of six items with total scores ranging from 0 to 30, where higher scores indicate greater functional impairment. |
| Perceived quality of life | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. | Change in total and domain scores on the WHO Quality of Life-BREF (WHOQOL-BREF; Lucas-Carrasco, 2012). The WHOQOL-BREF includes 26 items across multiple domains, with item scores ranging from 1 to 5. Higher scores indicate better perceived quality of life. |
| Transdiagnostic dimensions | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. | Change in scores across domains on the Multidimensional Emotional Disorder Inventory (MEDI; Rosellini \& Brown, 2019). The MEDI includes 49 items rated from 0 to 8, grouped into nine domains. Higher scores indicate greater severity of transdiagnostic emotional disorder dimensions. |
| Satisfaction with the program | Immediately after completion of the 3-month intervention. | Participant satisfaction will be assessed post-intervention using a 10-item questionnaire adapted from García-Escalera et al. (2020). Each item is rated on a 5-point Likert scale ranging from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater satisfaction. Some items are reverse coded prior to score calculation. |
| Use of healthcare resources | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. | Composite measure of healthcare utilization, including number of visits to healthcare services, missed treatment sessions, and number of medical tests performed. |
Countries
Spain
Contacts
CONTACTPatricia Fernández-Couto, Clinical Psychologist
PRINCIPAL_INVESTIGATORPatricia Fernández Couto, Clinical Psychologist
Servicio Riojano de Salud
Outcome results
None listed