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

2026年9月3日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Bergen Four-Day Treatment
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Patient Health Questionnaire (PHQ-9)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tampere University Hospital

合作者

Tampere University

调查人员

  • 首席研究员：Aino Mattila、Tampere University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月25日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • R26017

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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