- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07644130
Bergen Four-Day Treatment (B4DT) for Obsessive-Compulsive Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aino Mattila
- Phone Number: +358503439168
- Email: aino.mattila@pirha.fi
Study Contact Backup
- Name: Petra Sainio
- Phone Number: +358444811252
- Email: petra.sainio@pirha.fi
Study Locations
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Tampere, Finland
- Tampere University Hospital
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Contact:
- Email: petra.sainio@pirha.fi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Bergen Four-Day Treatment
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)
Time Frame: 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.
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From pre-assessment to the end of follow-up approximately four to six months.
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Obsessive-Compulsive Inventory - Revised (OCI-R)
Time Frame: From pre-assessment to the end of follow-up approximately four to six months.
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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.
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From pre-assessment to the end of follow-up approximately four to six months.
|
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Client Satisfaction Questionnaire (CSQ-8)
Time Frame: From pre-assessment to the end of follow-up approximately four to six months.
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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.
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From pre-assessment to the end of follow-up approximately four to six months.
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Credibility and Expectancy Questionnaire (CEQ)
Time Frame: approximately four months
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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.
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approximately four months
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Self-report for healthcare professionals (AIM, IAM, FIM)
Time Frame: approximately four months
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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.
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approximately four months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Time Frame: From pre-assessment to the end of follow-up approximately four to six months.
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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.
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From pre-assessment to the end of follow-up approximately four to six months.
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Generalized Anxiety Disorder Scale (GAD-7)
Time Frame: From pre-assessment to the end of follow-up approximately four to six months.
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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.
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From pre-assessment to the end of follow-up approximately four to six months.
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Work and Social Adjustment Scale (WSAS)
Time Frame: From pre-assessment to the end of follow-up approximately four to six months
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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.
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From pre-assessment to the end of follow-up approximately four to six months
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Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time Frame: From pre-assessment to the end of follow-up approximately four to six months.
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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.
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From pre-assessment to the end of follow-up approximately four to six months.
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EuroQol 5-Dimension Questionnaire (EQ-5D)
Time Frame: From pre-assessment to the end of follow-up approximately four to six months.
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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.
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From pre-assessment to the end of follow-up approximately four to six months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aino Mattila, Tampere University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R26017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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