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Bergen Four-Day Treatment (B4DT) for Obsessive-Compulsive Disorder

3 septembre 2026 mis à jour par: Tampere University Hospital

The aim of this study is to expand access to Bergen Four-Day Treatment (B4DT) in Finland and to integrate it into psychiatric care pathways at Tampere University Hospital (TAYS). A Bergen team has been established within TAYS Psychiatry and has been trained in collaboration with the B4DT team from HUS and the Norwegian developers. The objective of this study is to enhance understanding of the model's adaptability to the Finnish healthcare system, evaluate healthcare professionals' attitudes toward the intervention, and assess treatment outcomes.

The aim is to recruit approximately 35 patients for the study. Patients will be recruited from a minimum of three groups (15 patients) and up to a maximum of six groups (35 patients). The criteria for admission to B4DT and for participation in the study are identical. The treatment and the study may include patients receiving specialized psychiatric care at Tampere University Hospital who have been diagnosed with obsessive-compulsive disorder and who experience significant impairment due to their symptoms. In addition, personnel from TAYS Psychiatry who recommend and refer patients for B4DT will be recruited for the study. The estimated number of participating staff members is approximately 30.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

65

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • diagnosed with obsessive-compulsive disorder
  • willingness to participate in exposure-based treatment

Exclusion Criteria:

  • intellectual disability
  • autism spectrum disorder that precludes engagement in psychotherapeutic work
  • a psychotic disorder with current psychotic symptoms
  • underweight or very rapid weight loss affecting cognition
  • severe suicidality
  • substance dependence
  • benzodiazepine medication (use of Z-drugs as sleep medication is permitted)
  • In addition, ongoing psychotherapy may prevent participating in the B4DT.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bergen Four-Day Treatment
Autre: Bergen Four-Day Treatment (B4DT)
The intervention starts with a pre-assessment, during which patients' motivation, expectations, and willingness to engage in exposure practice are assessed. After the pre-assessment, patients participate in a four-day intensive treatment period based on exposure and response prevention. The intensive phase is an individualized intervention delivered within a group framework. This phase is followed by a three-month period of independent practice, with a couple of appointments with the therapist. Changes in patients' symptoms, daily functioning, and well-being are assessed. In addition, healthcare professionals' attitudes toward the intervention will be examined.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)
Délai: From pre-assessment to the end of follow-up approximately four to six months.
Changes in OCD symptoms will be assessed using the Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR), a ten-item self-report measure with each item rated from 0 to 4. Total scores range from 0 to 40, with higher scores indicating more severe symptoms.
From pre-assessment to the end of follow-up approximately four to six months.
Obsessive-Compulsive Inventory - Revised (OCI-R)
Délai: From pre-assessment to the end of follow-up approximately four to six months.
In addition to the Y-BOCS, changes in OCD symptoms will be assessed using the Obsessive-Compulsive Inventory - Revised (OCI-R), which consists of 18 items, each rated from 0 to 4, with total scores ranging from 0 to 72 points. Higher scores indicate more severe symptoms.
From pre-assessment to the end of follow-up approximately four to six months.
Client Satisfaction Questionnaire (CSQ-8)
Délai: From pre-assessment to the end of follow-up approximately four to six months.
Patients will be asked about their satisfaction with the treatment using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of eight items, each rated on a scale from 1 to 4, with total scores ranging from 8 to 32. Higher scores indicate greater satisfaction with the treatment.
From pre-assessment to the end of follow-up approximately four to six months.
Credibility and Expectancy Questionnaire (CEQ)
Délai: approximately four months
Patients' treatment expectations will be assessed using the Credibility and Expectancy Questionnaire (CEQ). The CEQ includes six items: four rated from 1 to 9 and two from 0% to 100%, with higher scores indicating greater expectations and confidence in the treatment.
approximately four months
Self-report for healthcare professionals (AIM, IAM, FIM)
Délai: approximately four months
The acceptability, appropriateness, and feasibility of the treatment will be assessed among healthcare professionals using a combination of three subscales: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). The AIM, IAM, and FIM each consist of four items rated on a five-point scale. Accordingly, the total score for each scale ranges from 4 to 20 points. The total 12-item score ranges from 12 to 60, with higher scores indicating greater overall treatment acceptability.
approximately four months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient Health Questionnaire (PHQ-9)
Délai: From pre-assessment to the end of follow-up approximately four to six months.
Secondarily, the aim is to investigate whether there are changes in patients' depressive symptoms during the treatment. Depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9), which consists of nine items, each rated from 0 to 3, with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms.
From pre-assessment to the end of follow-up approximately four to six months.
Generalized Anxiety Disorder Scale (GAD-7)
Délai: From pre-assessment to the end of follow-up approximately four to six months.
In addition to depressive symptoms, the aim is to examine whether there are changes in patients' anxiety symptoms during the treatment. Anxiety symptoms will be assessed using the Generalized Anxiety Disorder Scale (GAD-7), which consists of seven items scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.
From pre-assessment to the end of follow-up approximately four to six months.
Work and Social Adjustment Scale (WSAS)
Délai: From pre-assessment to the end of follow-up approximately four to six months
Work and social functioning will be assessed using the Work and Social Adjustment Scale (WSAS), a five-item measure rated on a Likert scale from 0 ("Not at all") to 8 ("Very much"). Total scores range from 0 to 40, with higher scores indicating greater impairment in work and social functioning.
From pre-assessment to the end of follow-up approximately four to six months
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Délai: From pre-assessment to the end of follow-up approximately four to six months.
General wellbeing will be assessed using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), which consists of 14 items rated on a five-point Likert scale from 1 "Never" to 5 "All the time," yielding total scores from 14 to 70. Higher scores indicate higher perceived wellbeing.
From pre-assessment to the end of follow-up approximately four to six months.
EuroQol 5-Dimension Questionnaire (EQ-5D)
Délai: From pre-assessment to the end of follow-up approximately four to six months.
Quality of life will be assessed using the EuroQol 5-Dimension Questionnaire (EQ-5D), which consists of five items scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate lower perceived well-being. In addition, the EQ-5D includes a one-item scale for self-assessed well-being ranging from 0 to 100%. Higher percentages indicate higher perceived well-being.
From pre-assessment to the end of follow-up approximately four to six months.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tampere University Hospital

Collaborateurs

Tampere University

Les enquêteurs

  • Chercheur principal: Aino Mattila, Tampere University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2026

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

25 mai 2026

Première soumission répondant aux critères de contrôle qualité

11 juin 2026

Première publication (Réel)

12 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R26017

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

The information sheet for research participants in this study states that the study data will not be shared and will be available only to researchers working for the Wellbeing Services County of Pirkanmaa. Patients will provide written consent only for this specific use of their personal data. This procedure has been approved by the ethics committee.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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