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

3 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

65

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Bergen Four-Day Treatment
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Health Questionnaire (PHQ-9)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tampere University Hospital

Medewerkers

Tampere University

Onderzoekers

  • Hoofdonderzoeker: Aino Mattila, Tampere University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

25 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 september 2026

Laatste update ingediend die voldeed aan QC-criteria

3 september 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R26017

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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