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Anxiety DisordersNCT06894368

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

A study testing UP-A in people with Anxiety Disorders and Depressive Disorder, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 18 years
What is being tested?
UP-A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSpain
Study dates
17 Nov 2022to 15 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Centro de Salud Mental de Majadahonda

    Madrid, Madrid, 28221

Other trials in Spain

About this study

Official title: Development and Evaluation of a Group Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in a Spanish Public Mental Health Setting.

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.

Read the detailed description

Anxiety and depression are among the most prevalent mental health disorders in adolescents, with growing concerns about their increasing incidence. Studies indicate that emotional disorders often co-occur due to shared transdiagnostic factors, such as poor emotion regulation, high negative affect, and cognitive avoidance. Given these shared mechanisms, transdiagnostic treatments like the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) have been developed to improve adaptive emotion regulation and reduce avoidance behaviors. While the UP-A has been primarily evaluated as an individual therapy, its adaptation to a group format could enhance accessibility and efficiency, particularly in public mental health settings.

This study aims to adapt the Spanish version of the UP-A to a group format for adolescents with moderate emotional symptoms in a public mental health setting and assess its clinical utility and feasibility. The program is administered at a public mental health center in Madrid, with 31 adolescents (ages 11-17) diagnosed with emotional disorders. The intervention consists of 16 weekly sessions for adolescents, alongside three parental sessions. The program incorporates modifications such as individual sessions for defining personal treatment goals, structured peer support, and behavioral reinforcement strategies.

Being tested
UP-A
Keywords
Unified Protocol, Emotional Disorders, Adolescents, Public Mental Health, UP-A, Spain
Medical subject headings
Anxiety Disorders, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UP-ABehavioural

    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.

Study groups in NCT06894368
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention Group of an uncontrolled study.
Receives: Behavioral: UP-A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: Up to 12 months

Secondary outcomes (12)

  1. 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.

    Range from 0 to 48. Depressive symptoms. Higher scores mean a worse outcome.

    Measured: Up to 12 months

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

    The 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2025
  2. Study start17 Nov 2022
  3. Primary completion15 Jun 2025
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06894368
Sponsor's protocol ID
1-PSI-2023/1
Status last verified
Sep 2025
First submitted
12 Mar 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cortes L, Garcia-Escalera J, Casanova I, Segura A, Valiente RM, Chorot P. Development and preliminary evaluation of a group adaptation of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in adolescents (UP-A) in a Spanish public mental health center. BMC Psychol. 2026 Sep 16;14(1):1456. doi: 10.1186/s40359-026-05472-8.

    PubMed 42850649

Questions about this trial

What is this clinical trial studying?

A study testing UP-A in people with Anxiety Disorders and Depressive Disorder, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30 (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06894368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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