Group Version of the UP-A in a Spanish Day Hospital for Adolescents.

NCT ID: NCT06894394

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-07-30

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.

Conditions

Anxiety Disorders; Depressive Disorder; Emotional Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Intervention Group of an uncontrolled study.

Group Type: EXPERIMENTAL

UP-A

Intervention Type: BEHAVIORAL

The UP-A (Ehrenreich-May et al., 2018, 2020, 2022) is a transdiagnostic intervention with eight modules targeting neuroticism. It improves emotion regulation and reduces avoidance, with summaries after each module and a Parent Module (P). The intervention is a group adaptation of the Spanish version of UP-A that consists of 16 weekly sessions, each lasting 60 to 90 minutes, held in person at a Day Hospital within the Spanish public healthcare system. Due to the complexity of the setting, parent sessions are not viable. However, parents receive summaries of the modules covered with the adolescents, as well as the Parent Module (Parenting the Emotional Adolescent), to support their understanding of the treatment content.

Interventions

UP-A

The UP-A (Ehrenreich-May et al., 2018, 2020, 2022) is a transdiagnostic intervention with eight modules targeting neuroticism. It improves emotion regulation and reduces avoidance, with summaries after each module and a Parent Module (P). The intervention is a group adaptation of the Spanish version of UP-A that consists of 16 weekly sessions, each lasting 60 to 90 minutes, held in person at a Day Hospital within the Spanish public healthcare system. Due to the complexity of the setting, parent sessions are not viable. However, parents receive summaries of the modules covered with the adolescents, as well as the Parent Module (Parenting the Emotional Adolescent), to support their understanding of the treatment content.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puerta de Hierro University Hospital

OTHER

Sponsor Role: collaborator

Universidad Nacional de Educación a Distancia

OTHER

Sponsor Role: lead

Responsible Party

Julia García Escalera

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosa M. Valiente, Professor

Role: STUDY_DIRECTOR

Universidad Nacional de Educación a Distancia

Locations

Hospital de Día Infantojuvenil del Hospital Puerta de Hierro de Majadahonda

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

1-PSI-2023/2

Identifier Type: -

Identifier Source: org_study_id