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

NCT06894394 | Completed

• 1 other identifier: 1-PSI-2023/2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorder; Emotional Disorder

Keywords

Unified Protocol; Emotional Disorders; Adolescents; Severe mental disorders; Day Hospital; UP-A; Spain

Outcome Measures

Primary Outcomes (4)

• Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30

  The Revised Child Anxiety and Depression Scale-30 (RCADS-30; Sandín et al., 2010) at pre, post-intervention and 3, 6 and 12 months follow-up. Range from 0 to 90. Symptoms of anxiety (panic disorder, social phobia, separation anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) and depressive disorders symptoms. Higher scores mean a worse outcome. Parents completed the "parent version" of the RCADS.

  Up to 12 months

• Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN

  Depression and Anxiety Interference Scale for Children and Adolescents EIDAN (Espinosa et al., 2022) . It is a 10-item self-reported instrument that evaluates the interference of emotional symptoms in the adolescent's daily functioning in the previous weeks, in several contexts (school, family and with peers). The higher the score, the higher the level of interference. Assessed at pre, post-intervention and 3, 6 and 12 months follow-up. Range from 10 to 40. Parents completed the "parent version" of the EIDAN.

  Up to 12 months

• Top Problems Measure

  The adolescent version of the Top Problem Assessment (TPA) (Ehrenreich, 2018; adapted from Weisz et al., 2011) was used to enhance treatment outcomes and strengthen the therapeutic alliance. Adolescents were asked to write down the issues that concerned them the most and assess the severity of each problem by rating its impact on daily functioning on a scale from 0 ("not a problem at all") to 10 ("very, very much a problem"). Each adolescent selected between one and three problems and evaluated their severity at five time points: at the beginning of the program (session 3), mid-treatment (session 8), the final session (session 16), and during follow-ups at 3, 6 and 12 months.

  Up to 12 months

• Changes in Emotion Regulation Strategies as Assessed by CERE

  Emotion Regulation Strategies Questionnaire CERE-II (Sandín et al., 2008). Adapted to Spanish by Sandín et al. (2008). Evaluates 7 subscales of the "emotion regulation" construct at pre, post-intervention and 3, 6 and 12 months follow-up. Higher scores in maladaptive regulation strategies (supression; rumination; distraction) and lower scores in adaptive strategies (attention/awareness/understanding; acceptance/tolerance; cognitive reappraisal; self-instructions) mean a worst outcome

  Up to 12 months

Secondary Outcomes (12)

• Changes in Positive and Negative Affect as Assessed by PANASN

  Up to 12 months

• Changes in Depressive Symptoms as Assessed by CDN

  Up to 12 months

• Changes in Anxiety Sensitivity as Assessed by CASI

  Up to 12 months

• Changes in Emotional Avoidance as Assessed by EASI

  Up to 12 months

• Changes in Satisfaction with Life as Assessed by SWLS

  Up to 12 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Intervention Group of an uncontrolled study.

Behavioral: UP-A

Interventions

UP-A 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.

Intervention group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional de Educación a Distancia: lead
• Puerta de Hierro University Hospital: collaborator

Study Sites (1)

Hospital de Día Infantojuvenil del Hospital Puerta de Hierro de Majadahonda

Madrid, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Mood Disorders

Study Officials

• Rosa M. Valiente, Professor

  Universidad Nacional de Educación a Distancia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: January 1, 2023
• Primary Completion: July 14, 2025
• Study Completion: July 30, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

ES (1)