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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 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

106

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.
Aktiver 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anxiety Symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Experiential avoidance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Patricia Fernández Couto

Mitarbeiter

University of La Rioja

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. April 2024

Primärer Abschluss (Geschätzt)

30. Juni 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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