Bergen Four-Day Treatment (B4DT) for Obsessive-Compulsive Disorder
11. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
65
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Aino Mattila
- Telefonní číslo: +358503439168
- E-mail: aino.mattila@pirha.fi
Studijní záloha kontaktů
- Jméno: Petra Sainio
- Telefonní číslo: +358444811252
- E-mail: petra.sainio@pirha.fi
Studijní místa
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Tampere, Finsko
- Tampere University Hospital
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Kontakt:
- E-mail: petra.sainio@pirha.fi
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)
Časové okno: From pre-assessment to the end of follow-up approximately four to six months.
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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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Patient Health Questionnaire (PHQ-9)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Aino Mattila, Tampere University Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. června 2026
Primární dokončení (Odhadovaný)
1. prosince 2027
Dokončení studie (Odhadovaný)
1. prosince 2027
Termíny zápisu do studia
První předloženo
25. května 2026
První předloženo, které splnilo kritéria kontroly kvality
11. června 2026
První zveřejněno (Aktuální)
12. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R26017
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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