Clinical trial NCT06894368: Group Version of the UP-A in a Spanish Public Mental Health Setting.
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Emotional Disorder
Keywords: Unified Protocol
Emotional Disorders
Adolescents
Public Mental Health
UP-A
Spain
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Puerta de Hierro University Hospital
First posted: 2025-03-25
Enrollment: 31
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Depressive Symptoms as Assessed by CDN
timeFrame: Up to 12 months
measure: Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30
timeFrame: Up to 12 months
measure: Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN
timeFrame: Up to 12 months
Secondary outcomes:
measure: Changes in Positive and Negative Affect as Assessed by PANASN
timeFrame: Up to 12 months
measure: Changes in Anxiety Sensitivity as Assessed by CASI
timeFrame: Up to 12 months
measure: Changes in Emotional Avoidance as Assessed by EASI
timeFrame: Up to 12 months
measure: Changes in Emotion Regulation Strategies as Assessed by CERE
timeFrame: Up to 12 months
measure: Changes in Satisfaction with Life as Assessed by SWLS
timeFrame: Up to 12 months
measure: Changes in Attachment Styles as Assessed by ARSQ
timeFrame: Up to 12 months
measure: Changes in Somatic Symptoms as Assessed by PHQ-15
timeFrame: Up to 12 months
measure: Changes in Severity of Clinical Diagnosis as Assessed by CSR
timeFrame: 16 weeks
measure: Changes in Level of Functioning as Assessed by CGAS
timeFrame: Up to 12 months
measure: Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S
timeFrame: Up to 12 months
measure: Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I
timeFrame: Up to 12 months
measure: Satisfaction with the program and therapeutic alliance
timeFrame: 16 weeks
measure: Top Problems Measure
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro de Salud Mental de Majadahonda
Study officials:
affiliation: Universidad Nacional de Educación a Distancia
name: Paloma Chorot, Professor
role: STUDY_DIRECTOR
References: