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Protocollo unificato per il trattamento dei disturbi emotivi in ​​brevi gruppi nei servizi di assistenza primaria in Spagna

6 novembre 2026 aggiornato da: Jorge Javier Osma López, Instituto de Investigación Sanitaria Aragón

Studio del rapporto costo-efficacia e accettabilità del Protocollo Unificato per il Trattamento dei Disturbi Emotivi in ​​Gruppi Brevi nei Servizi di Assistenza Primaria in Spagna (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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

180

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jorge Osma, Ph.D
  • Numero di telefono: 978645390
  • Email: osma@unizar.es

Luoghi di studio

    • Castellón
      • Vinaròs, Castellón, Spagna, 12500
        • Reclutamento
        • Hospital Comarcal de Vinaròs
        • Contatto:
          • Vanessa Ferreres
    • Valencia
      • Villarreal, Valencia, Spagna, 12540
        • Reclutamento
        • Centro de Salud Carinyena, Hospital Universitario de La Plana
        • Contatto:
          • Laura Camacho

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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

Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Multidimensional Emotional Disorder Inventory (MEDI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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]
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 febbraio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

7 agosto 2024

Primo inviato che soddisfa i criteri di controllo qualità

7 agosto 2024

Primo Inserito (Effettivo)

9 agosto 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • PID2023-151473OB-100

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Under request

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .