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Einheitliches Protokoll zur Behandlung emotionaler Störungen in Kurzgruppen in der Grundversorgung in Spanien

6. November 2026 aktualisiert von: Jorge Javier Osma López, Instituto de Investigación Sanitaria Aragón

Studie zur Kostenwirksamkeit und Akzeptanz des einheitlichen Protokolls zur Behandlung emotionaler Störungen in Kurzgruppen in der Grundversorgung in Spanien (PU-AP)

The aim of this project is to contribute to the improvement of psychological care received in primary care (PC), through the study of the cost-effectiveness and acceptability of the Unified Protocol for the treatment of emotional disorders in brief groups in primary care services in Spain (PU-AP) for the treatment of emotional disorders (EDs), the most prevalent in our society. To do so, a pilot study will be carried out, and, subsequently, a randomized clinical trial to study the efficacy, cost-effectiveness and acceptability of the Unified Protocol for the transdiagnostic treatment of EDs, applied in 5 or 8 group sessions. Finally, the researchers will analyze whether there are specific patient profiles that will benefit more from one or the other condition. The results will contribute to the personalization of the psychological treatment of users with EDs attending PC in the Spanish public health system.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Emotional disorders (EDs;including anxiety disorders, unipolar mood disorders, and related disorders) are the most prevalent mental disorders in the general population. In Spain, anxiety disorders and mood disorders affect approximately two million (4.1%) and two and half million (5.2%) individuals, respectively. As a result of their prevalence in the society, EDs have become an alarming health problem due to their associate costs. These disorders have a direct cost of 22.000 million euros (500 euros per capita and year). The total expense of these disorders entails 2.2% of the Gross Domestic Product in Spain.

In recent years, several alternatives have been proposed to address this situation, one of them being an increase in the number of clinical psychologists in our national health system (NHS) and, especially, their incorporation into primary care (PC) services.

It is considered that the incorporation of psychology in PC will help to reduce referral to specialized care because it will be possible to carry out a more exhaustive screening and determine which cases do not require psychological treatment, which cases should be referred to other health care resources and which cases can be treated in PC, usually mild-moderate TE. Another alternative to mitigate the excessive demand for care, regardless of the level of care, is the use of group psychological interventions, a cost-effective format for systems with limited resources such as our NHS.

Transdiagnostic interventions, like the Unified Protocol for the Treatment of EDs (UP), in brief group format, has emerged as a viable option for treating EDs in PC services.

The aim of the present study is to analyze the cost-effectiveness and acceptability of the Unified Protocol for the transdiagnostic treatment of EDs, applied in 5 or 8 group sessions.

Furthermore, it will try to find out which characteristics of the participants (e.g., gender, clinical diagnoses, transdiagnostic dimensions affected, symptom severity) predict a better outcome (e.g., clinical improvement and quality of life) as a function of the sessions received. Thus, in the future, it will be possible to offer the optimal number of sessions according to specific profiles (personalization of treatments).

Studientyp

Interventionell

Einschreibung (Geschätzt)

180

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: Jorge Osma, Ph.D
  • Telefonnummer: 978645390
  • E-Mail: osma@unizar.es

Studienorte

    • Castellón
      • Vinaròs, Castellón, Spanien, 12500
        • Rekrutierung
        • Hospital Comarcal de Vinaròs
        • Kontakt:
          • Vanessa Ferreres
    • Valencia
      • Villarreal, Valencia, Spanien, 12540
        • Rekrutierung
        • Centro de Salud Carinyena, Hospital Universitario de La Plana
        • Kontakt:
          • Laura Camacho

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Have at least one EDs diagnosis (anxiety, depressive, obsessive-compulsive, trauma and somatic disorders) from the ADIS-5 interview
  • Have a score between 0 and 5 severity (mild-moderate) on the diagnoses on the CSR of the ADIS-5
  • Be able to attend all assessment and treatment sessions
  • Individuals on pharmacological treatment will be asked to maintain the dosage for the duration of the study, unless there is a medical contraindication

Exclusion Criteria:

  • Absence of clinical diagnosis
  • Presenting a diagnosis of EDs with a severity score on diagnoses between 6 and 8 on the ADIS-5 CSR (severe) or a clinical condition requiring specialized mental health intervention such as presence of severe mental disorder (e.g., personality disorder, bipolar disorder, or schizophrenia), suicide risk at the time of assessment, or substance use in the past three months
  • Who have received 8 or more sessions of CBT (during the past five years) with techniques such as cognitive flexibility or exposure
  • Who are receiving psychological treatment.

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: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 5-session UP condition

In both conditions, the contents of the UP manual were worked following the 2nd edition of the UP manual (Barlow et al., 2018). In the 5-session version, Module 1 (Motivation for Change and Commitment to Treatment) was removed, and Modules 6 and 7 (Interoceptive and Emotional Exposure) were combined. The content of Module 8 (Achievement, Maintenance, and Relapse Prevention) was addressed during the follow-up session. The sessions were conducted in groups, lasted 2 hours each, and were held weekly.

Unified Protocol (UP) for transdiagnostic treatment of EDs in 5-session

Aktiver Komparator: 8-session UP condition

In both conditions, the contents of the UP manual were worked following the 2nd edition of the UP manual (Barlow et al., 2018). In the 8-session UP condition, each of the original 8 treatment modules was covered weekly. Module 7 (Emotional Exposure) was delivered across two sessions. The content of Module 8 (Achievement, Maintenance, and Relapse Prevention) was addressed during the follow-up session. The sessions were conducted in groups, lasted 2 hours each, and were held weekly.

Unified Protocol (UP) for transdiagnostic treatment of EDs in 8-session

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Zeitfenster: Enrollment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Diagnostic interview

Diagnostic interview

Enrollment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

The PHQ-9 (Patient Health Questionnaire-9) assesses depressive symptoms over the past two weeks using a 9-item scale. Each item is scored from 0 to 3, where 0 = "Not at all" and 3 = "Nearly every day". The total score range is 0-27, and is obtained by summing all item scores. Higher scores indicate more severe depressive symptoms.

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Overall Depression Severity and Impairment Scale (ODSIS)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4.

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Generalized Anxiety Disorder (GAD-7)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

The GAD-7 questionnaire assesses the presence of Generalized Anxiety Disorder (GAD), as listed in the DSM-V. The scale is composed by 7 items. Scores for all 7 items range from 0 (Not at all) and 3 (Nearly every day). Therefore, the total score ranges from 0 and 21. The total score may be categorized into four severity groups: minimal (0-4), mild (5-9), moderate (10-14) and serious (14-20)

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Overall Anxiety Severity and Impairment Scale (OASIS)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

The scale presents five items. These items are related with the frequency and intensity of anxiety symptoms and their interference with the person's work or school life and with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety).

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
The World Health Organization-Five Well-Being Index (WHO-5)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Is a self-report instrument measuring mental well-being. It consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Difficulties in Emotion Regulation Scale (DERS)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Consists of 36-item of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The Multidimensional Emotional Disorder Inventory (MEDI)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

A self-report measure that includes only 49 items and enables to quickly assess the main transdiagnostic dimensions of Emotional disorders: neurotic temperament (MEDI_NT), positive temperament (MEDI_PT), depressed mood (MEDI_DM), autonomic arousal (MEDI_AA), somatic anxiety (MEDI_SOM), intrusive cognitions (MEDI_IC), social concerns (MEDI_SOC), traumatic re-experiencing (MEDI_TRM), and avoidance (MEDI_AVD). It uses a 9-point Likert-type response scale (0 = Does not characterize me; 8 = Totally characterizes me).

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Working Alliance Inventory-Short (WAI-S)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Evaluate the therapeutic or working alliance through 12 items grouped in three dimensions, called task (1, 2, 10 and 12), links (3, 5, 7 and 9) and objectives (4, 6, 8 and 11) measured through a Likert-type scale with scores ranging from 1 = Never to 7 = Always.

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Maladjustment Scale (MI)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Evaluates interference in different vital areas through six items with a 6-point Likert-type response scale (0 = Not at all; 5 = Extremely).

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Adaptation of Client Satisfaction Questionnaire [CSQ-8]
Zeitfenster: At the end of treatment (approximately 5 or 8 weeks after enrollment), and 1-, 3-, and 6-month follow-ups after treatment completion.

An adaptation of 13 items that measures quality of the intervention and its components, discomfort experienced during treatment through the following 7 questions with a 4-point Likert-type response scale (0 = nothing; 3 =very much): 1) How would you rate the quality of the treatment program you received?; 2) Did you find the kind of psychological intervention you were looking for?; 3) If a friend or family member needed similar help, would you recommend our treatment program?; 4) Has the content you have learned helped you cope more effectively with your problems?; 5) Overall, how satisfied are you with the treatment program you received?; 6) To what extent has this treatment program caused you discomfort?; 7) If you had to seek help again, would you choose a group treatment program?

At the end of treatment (approximately 5 or 8 weeks after enrollment), and 1-, 3-, and 6-month follow-ups after treatment completion.
Group Climate Questionnaire (GCQ-S)
Zeitfenster: During treatment (2nd session)

The GCQ-S (Group Climate Questionnaire - Short) is a 12-item self-report measuring perceptions of the group's therapeutic environment, with each item rated 0-6 (total score 72). It has three subscales: Engagement (positive group atmosphere; higher scores = greater involvement), Conflict (tension and anger; higher scores = more interpersonal conflict), and Avoidance (withdrawal or evasion of responsibility; higher scores = more disengagement).

During treatment (2nd session)
Quality-adjusted Life Years (QALYs)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions.

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Work and Social Adjustment Scale (WSAS)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

The Work and Social Adjustment Scale (WSAS) identifies problems that affect an individual's ability to carry out everyday tasks. It consists of 5 items, each rated on a scale from 0 (Not at all) to 8 (Very severely). The total score is obtained by summing the ratings for all items, with a maximum possible score of 40. A WSAS score above 20 typically indicates moderately severe or worse psychopathology, while scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptoms.

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.
Client Service Receipt Inventory (CSRI)
Zeitfenster: Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

The Client Service Receipt Inventory (CSRI) is a self-report questionnaire that collects information on service use, including health and social care, medication, and other support services. The number of items varies depending on the version and study context, but it typically includes around 50-60 items. It is designed to evaluate the type, frequency, and duration of services used by clients, which can be used to estimate the associated costs and resource utilization.

Pre-treatment, post-treatment (5 or 8 weeks after intervention onset), and 1-, 3-, and 6-month follow-ups after treatment completion.

Mitarbeiter und Ermittler

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

Sponsor

Ermittler

  • Hauptermittler: Jorge Osma, Ph.D, Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza

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.

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)

10. Februar 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. September 2027

Studienanmeldedaten

Zuerst eingereicht

7. August 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. August 2024

Zuerst gepostet (Tatsächlich)

9. August 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PID2023-151473OB-100

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Under request

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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