ClinicalTrials.gg
CompletedNCT06894394Updated Sep 16, 2025

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

An interventional study of UP-A in Anxiety Disorders, Depressive Disorder and Emotional Disorder, sponsored by Universidad Nacional de Educación a Distancia. Completed at 1 site in Spain. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Universidad Nacional de Educación a Distancia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2023, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
11 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety Disorders
  • Depressive Disorder
  • Emotional Disorder

Keywords

  • Unified Protocol
  • Emotional Disorders
  • Adolescents
  • Severe mental disorders
  • Day Hospital
  • UP-A
  • Spain
03

In context

Anxiety Disorders

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 15 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Universidad Nacional de Educación a Distancia is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Intervention group

    Intervention Group of an uncontrolled study.

    Behavioral: UP-A

Interventions

  • BehavioralUP-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 months

  2. 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.

    Time frame: Up to 12 months

  3. 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.

    Time frame: Up to 12 months

  4. 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

    Time frame: Up to 12 months

Secondary outcomes

  1. Changes in Positive and Negative Affect as Assessed by PANASN

    he Children Positive and Negative Affect Schedule \[Escalas PANAS para niños y adolescentes\] (PANASN; Sandín, 2003) at pre, post-intervention and 3, 6 and 12 months follow-up. Positive and negative affect. Range 10-30. Higher scores of negative affect and lower scores os positive affect mean a worse outcome.

    Time frame: Up to 12 months

  2. Changes in Depressive Symptoms as Assessed by CDN

    The Depression Questionnaire for Children and Adolescents \[Cuestionario de Depresión para Niños y Adolescentes\] (CDN; Sandín et al., 2016) at pre, post-intervention and 3, 6 and 12 months follow-up. Depressive symptoms. Range from 0 to 48. Higher scores mean a worse outcome

    Time frame: Up to 12 months

  3. Changes in Anxiety Sensitivity as Assessed by CASI

    Childhood Anxiety Sensitivity Index CASI (Silverman et al., 1991) ; Spanish adaptation by (Sandín et al., 2002). Anxiety sensitivity at pre, post-intervention and 3, 6 and 12 months follow-up. Range 18 to 54. Higher scores mean a worse outcome.

    Time frame: Up to 12 months

  4. Changes in Emotional Avoidance as Assessed by EASI

    Emotional Avoidance Strategy Inventory for Adolescents EASI-A ( Kennedy \& Ehrenreich-May, 2017) ; Spanish adaptation by (García-Escalera et al., 2016). Emotional avoidance strategies at pre, post-intervention and 3, 6 and 12 months follow-up. Range 0 to 68. Higher scores mean a worse outcome.

    Time frame: Up to 12 months

  5. Changes in Satisfaction with Life as Assessed by SWLS

    Satisfaction with Life Scale SWLS (Diener et al., 2010; adapted to Spanish by Sandín et al., 2015). Evaluates satisfaction with life at pre, post-intervention and 3, 6 and 12 months follow-up. Range 5 to 20. Lower scores mean a worse outcome.

    Time frame: Up to 12 months

  6. Changes in Attachment Styles as Assessed by ARSQ

    Adolescent Relationships Scales Questionnaire ARSQ (Scharfe, 1999) ; adapted to Spanish by (Magaz et al., 2011). The ARSQ is an instrument composed of 17 self-reported items, which allows obtaining scores for the three types of attachment identified in the theory of Bartholomew (1990) and Bartholomew and Horowitz (1991): secure attachment, fearful/preoccupied attachment, and avoidant attachment. Evaluates attachment styles at pre, post-intervention and 3, 6 and 12 months follow-up. Higher scores in insecure attachment styles (fearful/preoccupied attachment, and avoidant attachment) and lower scores in secure attachment style mean a worst outcome.

    Time frame: Up to 12 months

  7. Changes in Somatic Symptoms as Assessed by PHQ-15

    Somatic Symptoms Scale extracted from the PHQ-15, Patient Health Questionnaire (adapted from the patient health questionnaire - physical symptoms - PHQ-15; (Kroenke et al., 2002) ; Extracted and translated from the APA website - DSM-5 Level 2 Cross -Cutting Symptom Measures). It is composed of 13 items that evaluate somatic symptoms in adolescents between 11 and 17 years old at pre, post-intervention and 3, 6 and 12 months follow-up. Range 0 to 26. Higher scores mean a worse outcome.

    Time frame: Up to 12 months

  8. Changes in Severity of Clinical Diagnosis as Assessed by CSR

    The Clinician Severity Rating CSR (ADIS-IV Interview; Silverman et al., 2008). This scale indicates, for each main and secondary diagnosis, the clinician's estimate of severity according to the following scale from 0 to 8: 0 = no seriousness, 1 - 2 = little disturbance/no disabling, 3 - 5 = clear disturbance/disabling (at least a 4 is required for diagnosis) 6 - 7 = high/disabling disturbance; 8 = very serious/disabling disturbance. Assessed at pre and post-treatment.

    Time frame: 16 weeks

  9. Changes in Level of Functioning as Assessed by CGAS

    The Children's Global Assessment Scale CGAS (Schaffer et al., 1983; version translated into Spanish by the Xunta de Galicia Agreement and the University of A Coruña Foundation, 2012). It is a clinician-estimated measure of the adolescent's overall level of functioning in the last month. Scores range from 100-91 (optimal functioning in all areas) to 10-1 (constant need for supervision). Evaluates General Functioning at pre, post-intervention and 3, 6 and 12 months follow-up.

    Time frame: Up to 12 months

  10. Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S

    The Clinical Global Impression (Severity) Scale CGI-S (Guy, 1976) . Using this scale, the clinician estimated the severity of the adolescent's anxiety and depression symptoms. Scores will range from 1 ("Normal, not at all ill"), to 7 ("Extremely ill"). Evaluated at pre, post-intervention and 3, 6 and 12 months follow-up.

    Time frame: Up to 12 months

  11. Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I

    The Clinical Global Impressions (Improvement) Scale CGI-I (Guy, 1976) . This scale was completed by the clinicians during post-treatment and follow-ups. The adolescent's improvement was scored on a scale from 1 to 7, with 1 being "very much improved" and 7 being "very much worse". Assessed at post-intervention and 3, 6 and 12 months follow-up.

    Time frame: Up to 12 months

  12. Satisfaction with the program and therapeutic alliance

    In the post-treatment evaluation, adolescents and involved parents completed a 12-item questionnaire that evaluates satisfaction with the program and the quality of the relationship with the therapist (Sandín et al., 2020).

    Time frame: 16 weeks

07

Study locations

1 site
  • Hospital de Día Infantojuvenil del Hospital Puerta de Hierro de Majadahonda
    Madrid, Madrid 28222, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06894394
Lead sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Puerta de Hierro University Hospital
Responsible party
Julia García Escalera (Professor, Universidad Nacional de Educación a Distancia) — Principal investigator
First posted
Mar 25, 2025
Start date
Jan 1, 2023
Primary completion
Jul 14, 2025
Completion
Jul 30, 2025
Last update
Sep 16, 2025

Study contacts

Rosa M. Valiente, Professor
study director · Universidad Nacional de Educación a Distancia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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