Clinical trial NCT06894394: Group Version of the UP-A in a Spanish Day Hospital for Adolescents.
Official title: Implementing a Group Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in a Spanish Day Hospital for Adolescents With Severe Mental Disorders.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Emotional Disorder
Keywords: Unified Protocol
Emotional Disorders
Adolescents
Severe mental disorders
Day Hospital
UP-A
Spain
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Puerta de Hierro University Hospital
First posted: 2025-03-25
Enrollment: 15
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to adapt the Spanish version of the UP-A for group delivery in an intensive treatment setting for adolescents with severe mental disorders within a day hospital of the Spanish public healthcare system. It also explores the feasibility and clinical utility of this adaptation through an uncontrolled study with pre-post and follow-up assessments (at 3, 6 and 12 months). The evaluation includes anxiety, depression, transdiagnostic variables, engagement, and satisfaction from adolescents, parents, and clinicians, as well as changes in adolescents' primary problems.

Detailed description: Anxiety and depression are among the most prevalent mental health disorders in adolescents, often co-occurring due to shared transdiagnostic factors such as poor emotion regulation, high negative affect, and cognitive avoidance. When severe, these disorders significantly increase the risk of self-harm and suicide, which is a leading cause of death among young people worldwide. Given these risks, it is crucial to develop interventions that effectively target these transdiagnostic mechanisms and improve access to treatment for adolescents with severe emotional disorders.

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) was designed to target neuroticism, a key vulnerability factor in emotional disorders. While the UP-A was originally developed as an individual treatment, its adaptation to a group format could enhance accessibility and optimize mental health resources. Although the UP has been successfully implemented in group settings for adults, there is limited research on the feasibility of a group-based UP-A intervention, particularly in clinical settings with adolescents experiencing severe mental health conditions.

This study aims to adapt the Spanish version of the UP-A to a group format in an intensive treatment setting, specifically within a day hospital of the Spanish public healthcare system, where adolescents receive comprehensive, multidisciplinary care for severe emotional disorders. The study also explores the feasibility and clinical utility of this adaptation through an uncontrolled study, assessing pre-post and follow-up outcomes in two consecutive groups. The intervention consists of 16 weekly sessions, each lasting 60 to 90 minutes.

The study evaluates changes in anxiety, depression, transdiagnostic variables (e.g., emotional avoidance, emotion regulation strategies), engagement, and satisfaction from the perspectives of adolescents, parents, and clinicians. Additionally, adolescents' self-rated primary problems and clinicians' assessments of overall clinical progress were analyzed. Follow-up assessments will be conducted 3, 6 and 12 months post-intervention to measure sustained effects.

Eligibility criteria: Inclusion Criteria:

* Being an active patient at the Day Hospital of the Puerta de Hierro Hospital
* Presenting, as the main diagnosis (most serious diagnosis or the one that interferes the most), an emotional disorder with moderate or high severity including the following disorders based on DSM-5 categories: Depressive Disorders (Major Depressive Disorder and Persistent Depressive Disorder), Bipolar Disorders (Bipolar I and II Disorder, Cyclothymic Disorder), Anxiety Disorders (Specific Phobia, Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder), Obsessive-Compulsive and Related Disorders (including Body Dysmorphic Disorder, Hoarding Disorder, Trichotillomania and Excoriation (Skin-Picking) Disorder), Trauma and Stressor-Related Disorders (Reactive Attachment Disorder, Post-Traumatic Stress Disorder, Acute Stress Disorder and Adjustment Disorders), Dissociative Disorders (Dissociative Identity Disorder, Depersonalization/Derealization Disorder) and Somatic Symptom and Related Disorders (Somatic Symptom Disorder and Illness Anxiety Disorder). Specified and unspecified disorders from the above categories are also included.
* Being able to participate normally in group therapy (despite presenting self-harm or suicidal ideation, severe depressive disorder or dysfunctional personality and/or autism spectrum disorder)
* Being 11-18 years of age
* Being proficient in Spanish
* Being able to attend the evaluation and treatment sessions
* At least one of the adolescent's parents or legal guardians being able to complete the evaluation questionnaires
* If the participant was taking psychiatric medication, the dose being remaining stable for at least 1 month before the start of treatment and throughout it

Exclusion Criteria:

* Presenting one or more of the following clinical conditions (either as a main or comorbid diagnosis): 1) Intellectual Disability, 2) Autism Spectrum Disorder accompanied by an intellectual disability that does not allow for group therapeutic work, 3) Disruptive, Impulse-Control and Conduct Disorders with a severity level that hinders group work, 4) Eating Disorders as the main diagnosis, 5) Psychotic Spectrum Disorders or psychotic-type symptoms, 6) Substance Abuse Disorders (excluding cannabis, coffee and/or nicotine) as the main diagnosis
* The characteristics or severity of the symptoms presented by the adolescent requiring an individual intervention or one adapted to the specific clinical condition
* Suffering from a serious medical illness that makes the adolescent's participation in the treatment program unsustainable
* The participant, or, if under 16 years of age, his or her parents, having refused to sign the informed consent

Primary outcomes:
measure: Changes in Depressive Symptoms as Assessed by CDN
timeFrame: Up to 12 months
measure: Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30
timeFrame: Up to 12 months
measure: Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN
timeFrame: Up to 12 months
Secondary outcomes:
measure: Changes in Positive and Negative Affect as Assessed by PANASN
timeFrame: Up to 12 months
measure: Changes in Anxiety Sensitivity as Assessed by CASI
timeFrame: Up to 12 months
measure: Changes in Emotional Avoidance as Assessed by EASI
timeFrame: Up to 12 months
measure: Changes in Emotion Regulation Strategies as Assessed by CERE
timeFrame: Up to 12 months
measure: Changes in Satisfaction with Life as Assessed by SWLS
timeFrame: Up to 12 months
measure: Changes in Attachment Styles as Assessed by ARSQ
timeFrame: Up to 12 months
measure: Changes in Somatic Symptoms as Assessed by PHQ-15
timeFrame: Up to 12 months
measure: Changes in Severity of Clinical Diagnosis as Assessed by CSR
timeFrame: 16 weeks
measure: Changes in Level of Functioning as Assessed by CGAS
timeFrame: Up to 12 months
measure: Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S
timeFrame: Up to 12 months
measure: Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I
timeFrame: Up to 12 months
measure: Satisfaction with the program and therapeutic alliance
timeFrame: 16 weeks
measure: Top Problems Measure
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital de Día Infantojuvenil del Hospital Puerta de Hierro de Majadahonda
Study officials:
affiliation: Universidad Nacional de Educación a Distancia
name: Rosa M. Valiente, Professor
role: STUDY_DIRECTOR
References: