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

11 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

65

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Bergen Four-Day Treatment
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient Health Questionnaire (PHQ-9)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tampere University Hospital

Współpracownicy

Tampere University

Śledczy

  • Główny śledczy: Aino Mattila, Tampere University Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

25 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • R26017

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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