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Efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents With Moderate Emotional Symptoms in Educational Settings

Efficacy of the Unified Protocol for Transdiagnostic Treatment for Adolescents With Symptoms of Anxiety and Depression: a School-based Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05322642
Acronym
PSICE
Enrollment
300
Registered
2022-04-12
Start date
2021-12-01
Completion date
2024-01-30
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder, Depressive Disorder, Emotional Problem, Emotional Disorder

Keywords

adolescents, depression, anxiety, emotional problems, transdiagnostic, school, evidence-based

Brief summary

The main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment.

Detailed description

Emotional problems, such as anxiety and depression, are among the leading causes of associated disability and burden of disease worldwide among young people. Therefore, it is necessary to address this emerging social challenge through the implementation of prevention strategies in relevant stages of development such as adolescence. In recent years, a transdiagnosis approach to emotional disorders has been promoted, highlighting the unified protocol for transdiagnostic treatment of emotional disorders and symptoms in its different versions (adulthood, adolescence, and childhood). In this context, the main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment. Adolescents aged 12-18 at high risk of for anxiety and depression disorders (cut-off scores 10-15 points, PHQ-9 and GAD-7) are selected. The design is a randomized controlled trial with two groups: active control (relaxation) and experimental (UP-A). Pre-test, post-test, and follow-up at 6, 12 and 18 months will be carried out. The impact of different behavioural, cognitive, affective, social, and academic functioning indicators is analyzed, as well as their effects in the short, medium, and long term. The satisfaction of the program by users (students, parents, and professionals) will also be evaluated. The implementation and validation of manualized and empirically validated psychological intervention programs, such as UP-A, should be a priority in educational and socio-health policies.

Interventions

BEHAVIORALUPA

UP-A is divided into five main treatment modules and three optional modules. The UP-A seek to positively affect how adolescents with anxiety and/ or depression experiences, think about, and respond to a broad range of negative and positive emotions, rather than disorder-specific emotions (e.g., fear, sadness).

BEHAVIORALActive control condition (Progressive Relaxation Training)

Progressive Relaxation Training (Bernstein and Borkovec) program is divided in ten sessions. Relaxation training often is used in behavior therapy as a means to reduce anxiety, tension, and stress. The goal is to release tension from your muscles, while helping you recognize what that tension feels like.

Sponsors

Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo
CollaboratorOTHER
Consejo General de la Psicología de España
CollaboratorUNKNOWN
Eduardo Fonseca Pedrero
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Be 12-18 years old * Written informed consent from adolescent and legal guardian * Being able to understand and read Spanish. * Moderate depressive and anxiety symptoms according to the screening (score moderate level in the PHQ-9 and GAD-7).

Exclusion criteria

* Being diagnosed a mental disorder or alcohol and/or substance dependence disorder. * The presence of high suicidal risk * A medical disease or condition which prevent the participant from carry out the psychological treatment. * Receiving another psychological treatment while the study is still ongoing. * The increase and/or changes in the medication of participants receiving pharmacological treatment during the study

Design outcomes

Primary

MeasureTime frameDescription
Depression symptomsBaseline to 18 months after start of interventionsChange in the Patient Health Questionnaire-9 (PHQ-9) total score. PHQ-9 total score for the nine items ranges from 0 to 27.Higher scores mean a worse outcome.
Anxiety symptomsBaseline to 18 months after start of interventionsChange in the Generalised Anxiety Disorder Assessment (GAD-7) total score. GAD-7 total score for the seven items ranges from 0 to 21.Higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
Positive and Negative AffectBaseline to 18 months after start of interventionsChange in the Positive and Negative Affect Schedule-Brief child (PANAS-Child brief version) scores. Total scores range (both positive and negative Affect) from 5 to 25. For Positive Affect dimension Higher scores mean a better outcome. For Negative Affect dimension higher scores mean a worse outcome.
Emotional and behavioural problemsBaseline to 18 months after start of interventionsChange in the Strengths and Difficulties Questionnaire (SDQ) total score. Total dificulties score range from 0 to 40. Higher scores mean a worse outcome.
Educational achievement outcomeBaseline to 18 months after start of interventionsEducational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome.
Transdiagnostic dimensionsBaseline to 18 months after start of interventionsChange in Multidimensional Emotional Disorders Inventory (MEDI) scores. Total score range from 0 to 392 Higher scores mean a worse outcome.
Health-related quality of lifeBaseline to 18 months after start of interventionsChange in the Kidscreeen-10 (Health-related quality of life) total score. Total score range from 10 to 50. Higher scores mean a better outcome.

Countries

Spain

Contacts

Primary ContactEduardo Fonseca-Pedrero, PHD
eduardo.fonseca@unirioja.es941293222
Backup ContactEduardo Fonseca Pedrero, phd
eduardo.fonseca@unirioja.es941293222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026