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Effectiveness of the Group Unified Protocol for Emotional Disorders in Adults in a Public Mental Health Setting (PSIGTE)

30. juni 2026 opdateret af: Patricia Fernández Couto

Effectiveness of the Group Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al. 2011, 2019a, 2019b) in Adults in a Public Mental Health Setting

This study has three primary objectives:

  1. To adapt the Spanish version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011, 2019a, 2019b) for delivery in a group format within the Spanish Public Mental Health System for adults diagnosed with emotional disorders.
  2. To evaluate the effectiveness of the intervention.
  3. To assess its clinical feasibility and acceptability in routine clinical practice.

Outcomes will include anxiety, depression, somatic symptoms, transdiagnostic variables, functional impairment, quality of life, and participant satisfaction. These outcomes will be assessed at baseline, post-treatment, and 3-month follow-up.

The intervention is expected to improve emotional symptoms, functional impairment, and quality of life. In addition, the study will explore whether this group-based transdiagnostic approach may help lower demand on public mental health services.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Anxiety and depressive disorders are among the leading causes of disability and contributors to the global burden of disease worldwide. To address this public health challenge, stepped-care models have been developed to organize treatment according to patients' clinical needs and progression. Within this framework, the transdiagnostic approach proposes that emotional disorders share common underlying transdiagnostic mechanisms, including elevated negative affect and maladaptive emotion regulation strategies such as emotional avoidance.

Accordingly, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) has emerged as an evidence-based intervention for anxiety, depressive, and related emotional disorders. The UP aims to enhance adaptive emotion regulation and lower maladaptive behavioral avoidance, thereby promoting improvements across a broad range of emotional symptoms.

This study aims to adapt and implement the Spanish version of the UP in a group format for adults diagnosed with an emotional disorder receiving treatment within the Spanish Public Mental Health System. In addition, the study will evaluate the intervention's effectiveness, feasibility, acceptability, and cost-effectiveness. The intervention will be delivered in Public Mental Health Units of the La Rioja Health Service.

Adults aged 18 to 65 years diagnosed with an emotional disorder will be recruited. The study will employ a randomized controlled trial design with two parallel groups: a Treatment as Usual (TAU) group and an experimental group (UP + TAU). Assessments will be conducted at pre-treatment, post-treatment, and 3-month follow-up. Outcome measures will assess anxiety, depression, somatic symptoms, transdiagnostic processes, functional impairment, quality of life, participant satisfaction, and intervention cost-effectiveness.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

106

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Patricia Fernández-Couto, Clinical Psychologist
  • Telefonnummer: 80324 (+34)941296251
  • E-mail: pafernco@unirioja.es

Studiesteder

  • Spanien
    • La Rioja
      • Logroño, La Rioja, Spanien, 26007
        • Rekruttering
        • Centro de Salud Espartero
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Aged 18 to 65 years.
  • Ability and willingness to provide written informed consent.
  • Sufficient proficiency in Spanish to participate in the intervention and complete study assessments.
  • Sufficient cognitive capacity to understand the intervention content.
  • A primary diagnosis of an emotional disorder with mild, moderate, or severe symptom severity, including Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive and Related Disorders, Trauma and Stressor-Related Disorders, Dissociative Disorders and Somatic Symptom and Related Disorders.
  • Presence of emotional symptoms (e.g., anxiety, depressive, or phobic symptoms), somatic symptoms, obsessive symptoms, and/or avoidance behaviors associated with clinically significant impairment, as indicated by moderate or higher scores on the GAD-7, PHQ-9, and/or PHQ-15.

Exclusion Criteria:

  • Refusal to provide informed consent or withdrawal of consent during the study.
  • Current severe substance use disorder or behavioral addiction.
  • Current high suicide risk.
  • Current psychotic symptoms or psychotic disorder.
  • Neurological disorders or severe medical conditions that could interfere with participation in or adherence to the intervention.
  • Intellectual disability, significant language difficulties, or any other condition that may impair the participant's ability to understand the intervention content.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 3-month Unified Protocol + Treatment as Usual
The UP (Barlow et al., 2011, 2019a, 2019b) is an emotion-focused, transdiagnostic cognitive-behavioral therapy for adults. Participants will receive a 9-session group-based adaptation of the UP, delivered in addition to treatment as usual (TAU). The program is designed for adults with emotional disorders receiving care within the Spanish Public Mental Health System.
Adfærdsmæssigt: UP
The UP includes eight modules designed to enhance emotion regulation skills: (1) Motivation Enhancement and Goal Setting; (2) Psychoeducation and Tracking Emotional Experiences; (3) Training in Present-Focused Emotional Awareness; (4) Cognitive Flexibility; (5) Countering Emotional Behaviors; (6) Understanding and Tolerating Physical Sensations; (7) Emotional Exposure; and (8) Recognizing Achievements and Maintaining Progress.
Aktiv komparator: 3-month Treatment as Usual
Participants assigned to the control group will receive treatment as usual (TAU) provided by the collaborating Public Mental Health Units. TAU will be delivered individually by the participant's assigned mental health professional and may include psychological and/or pharmacological treatment according to routine clinical practice.
Adfærdsmæssigt: TAU
TAU in the Public Mental Health Units of the La Rioja Health Service consists of care provided by specialists in Clinical Psychology and/or Psychiatry in accordance with routine clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anxiety Symptoms
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006). The GAD-7 consists of seven items with total scores ranging from 0 to 21, where higher scores indicate greater anxiety symptom severity.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Depressive Symptoms
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The PHQ-9 includes nine items with total scores ranging from 0 to 27, where higher scores indicate greater depressive symptom severity.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Somatic Symptoms
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Patient Health Questionnaire-15 (PHQ-15; Kroenke et al., 2010). The PHQ-15 consists of fifteen items with total scores ranging from 0 to 30, where higher scores indicate greater somatic symptom severity.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Experiential avoidance
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Acceptance and Action Questionnaire-II (AAQ-II; Ruiz et al., 2013). The AAQ-II includes seven items with total scores ranging from 7 to 42, where higher scores reflect greater experiential avoidance.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Functional impairment
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total score on the Inadaptation Scale (EI; Echeburúa et al., 2000). The EI consists of six items with total scores ranging from 0 to 30, where higher scores indicate greater functional impairment.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Perceived quality of life
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in total and domain scores on the WHO Quality of Life-BREF (WHOQOL-BREF; Lucas-Carrasco, 2012). The WHOQOL-BREF includes 26 items across multiple domains, with item scores ranging from 1 to 5. Higher scores indicate better perceived quality of life.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Transdiagnostic dimensions
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Change in scores across domains on the Multidimensional Emotional Disorder Inventory (MEDI; Rosellini & Brown, 2019). The MEDI includes 49 items rated from 0 to 8, grouped into nine domains. Higher scores indicate greater severity of transdiagnostic emotional disorder dimensions.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Satisfaction with the program
Tidsramme: Immediately after completion of the 3-month intervention.
Participant satisfaction will be assessed post-intervention using a 10-item questionnaire adapted from García-Escalera et al. (2020). Each item is rated on a 5-point Likert scale ranging from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater satisfaction. Some items are reverse coded prior to score calculation.
Immediately after completion of the 3-month intervention.
Use of healthcare resources
Tidsramme: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
Composite measure of healthcare utilization, including number of visits to healthcare services, missed treatment sessions, and number of medical tests performed.
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Patricia Fernández Couto

Samarbejdspartnere

University of La Rioja

Efterforskere

  • Ledende efterforsker: Patricia Fernández Couto, Clinical Psychologist, Servicio Riojano de Salud

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. april 2024

Primær færdiggørelse (Anslået)

30. juni 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEImLar P.I. 675
  • CEImLar P.I.675 (Anden identifikator: Research Ethics Committee for Medicines of La Rioja)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The study team does not plan to share de-identified individual participant data. Only aggregated data will be made available through scientific publications and conference presentations.

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