Implementing a Group Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in a Spanish Day Hospital for Adolescents With Severe Mental Disorders.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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
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 informed consent
Arms & Interventions
Intervention group
Intervention Group of an uncontrolled study.
Intervention: UP-A (Behavioral)
Outcomes
Primary Outcomes
Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30
Time Frame: Up to 12 months
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.
Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN
Time Frame: Up to 12 months
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.
Top Problems Measure
Time Frame: Up to 12 months
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.
Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30
Time Frame: Up to 12 months
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.
Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN
Time Frame: Up to 12 months
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.
Top Problems Measure
Time Frame: Up to 12 months
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.
Changes in Emotion Regulation Strategies as Assessed by CERE
Time Frame: Up to 12 months
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
Secondary Outcomes
- Changes in Somatic Symptoms as Assessed by PHQ-15(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)
- Changes in Attachment Styles as Assessed by ARSQ(Up to 12 months)
- Changes in Severity of Clinical Diagnosis as Assessed by CSR(16 weeks)
- Changes in Level of Functioning as Assessed by CGAS(Up to 12 months)
- Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S(Up to 12 months)
- Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I(Up to 12 months)
- Satisfaction with the program and therapeutic alliance(16 weeks)
- 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 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)
- Changes in Attachment Styles as Assessed by ARSQ(Up to 12 months)
- Changes in Somatic Symptoms as Assessed by PHQ-15(Up to 12 months)
- Changes in Severity of Clinical Diagnosis as Assessed by CSR(16 weeks)
- Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I(Up to 12 months)
- Changes in Level of Functioning as Assessed by CGAS(Up to 12 months)
- Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S(Up to 12 months)
- Satisfaction with the program and therapeutic alliance(16 weeks)
Investigators
Julia García Escalera
Professor
Universidad Nacional de Educación a Distancia