NCT07644130

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

May 25, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

BergenB4DTintensive treatmentOCD

Outcome Measures

Primary Outcomes (5)

  • Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)

    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)

    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)

    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)

    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)

    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

Secondary Outcomes (5)

  • Patient Health Questionnaire (PHQ-9)

    From pre-assessment to the end of follow-up approximately four to six months.

  • Generalized Anxiety Disorder Scale (GAD-7)

    From pre-assessment to the end of follow-up approximately four to six months.

  • Work and Social Adjustment Scale (WSAS)

    From pre-assessment to the end of follow-up approximately four to six months

  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

    From pre-assessment to the end of follow-up approximately four to six months.

  • EuroQol 5-Dimension Questionnaire (EQ-5D)

    From pre-assessment to the end of follow-up approximately four to six months.

Study Arms (1)

Bergen Four-Day Treatment

EXPERIMENTAL
Other: Bergen Four-Day Treatment (B4DT)

Interventions

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.

Bergen Four-Day Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Aino Mattila

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 12, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations