Group Version of the UP-A in a Spanish Public Mental Health Setting.

NCT06894368 | Completed

• 1 other identifier: 1-PSI-2023/1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to adapt the Spanish version of the UP-A to a group format in a public mental health setting for adolescents with moderate emotional symptoms and evaluate its clinical utility and feasibility. This includes assessing anxiety, depression, transdiagnostic variables, engagement, and satisfaction from adolescents, parents, and clinicians, with follow-ups at 3, 6 and 12 months. The goal is to improve adolescent mental health and explore whether this approach could help alleviate the pressure on public healthcare services.

Conditions

Anxiety Disorders; Depressive Disorder; Emotional Disorder

Keywords

Unified Protocol; Emotional Disorders; Adolescents; Public Mental Health; 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 Depressive Symptoms as Assessed by CDN

  Up to 12 months

• Changes in Positive and Negative Affect as Assessed by PANASN

  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 intervention is a group adaptation of the Spanish version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018, 2020, 2022). It consists of 16 weekly 90-minute sessions held in person at a public Mental Health Center. The intervention also includes three in-person group sessions for parents, each lasting one hour, held at the beginning, middle, and end of the program. These sessions cover content from the therapist's guide, including the Parent Module (Parenting the Emotional Adolescent), and provide a space for questions and emotional support.

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:

• Presenting a primary diagnosis of an emotional disorder with mild or moderate severity, including the following disorders based on DSM-5 categories: Depressive Disorders (Major Depressive Disorder and Persistent Depressive 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 were also included.
• Being 11-18 years of age
• Being proficient in Spanish
• The adolescent being able to attend the treatment sessions
• At least one of the adolescent's parents or legal guardians being able to attend the parents' treatment sessions
• If the participant was taking psychiatric medication, the dose was required to remain stable for at least 1 month before the start of treatment and throughout it

You may not qualify if:

• Presenting self-harm or suicidal ideation in a moderate or severe degree
• Presenting certain of the following clinical conditions (either as a main or comorbid diagnosis): Neurodevelopmental Disorders (Intellectual Disability or Autism Spectrum Disorder); Disruptive, Impulse-Control and Conduct Disorders; Eating Disorders; Psychotic Spectrum Disorders or psychotic-type symptoms,; Substance Abuse Disorders (excluding cannabis, coffee and/or nicotine); high severity Emotional Disorders; and Bipolar Disorders
• The characteristics or severity of the symptoms presented by the adolescent requiring an individual intervention or one adapted to the specific clinical condition
• Be receiving public or private psychological treatment during the UP-A program
• Suffering from a serious medical illness that made 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)

Centro de Salud Mental de Majadahonda

Madrid, Madrid, 28221, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Paloma Chorot, 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: November 17, 2022
• Primary Completion: June 15, 2025
• Study Completion: July 15, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

ES (1)