Health Trials

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

ConditionObsessive Compulsive Disorder (OCD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTampere University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed with obsessive-compulsive disorder

willingness to participate in exposure-based treatment

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Bergen Four-Day Treatment (B4DT)

    Other intervention

    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.

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Bergen Four-Day TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From pre-assessment to the end of follow-up approximately four to six months.
2

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.

Time frame
From pre-assessment to the end of follow-up approximately four to six months.
3

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.

Time frame
From pre-assessment to the end of follow-up approximately four to six months.
4

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.

Time frame
approximately four months

Secondary outcomes

1

Patient Health Questionnaire (PHQ-9)

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.

Time frame
From pre-assessment to the end of follow-up approximately four to six months.
2

Generalized Anxiety Disorder Scale (GAD-7)

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.

Time frame
From pre-assessment to the end of follow-up approximately four to six months.
3

Work and Social Adjustment Scale (WSAS)

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.

Time frame
From pre-assessment to the end of follow-up approximately four to six months
4

Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

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.

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

Other outcomes

Sponsors and contacts

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Tampere University Hospital

Lead sponsor

Tampere University

Collaborator

Source ClinicalTrials.gov
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