Bergen Four-Day Treatment (B4DT) for Obsessive-Compulsive Disorder
2026년 6월 11일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
65
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Aino Mattila
- 전화번호: +358503439168
- 이메일: aino.mattila@pirha.fi
연구 연락처 백업
- 이름: Petra Sainio
- 전화번호: +358444811252
- 이메일: petra.sainio@pirha.fi
연구 장소
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Tampere, 핀란드
- Tampere University Hospital
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연락하다:
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Yale-Brown Obsessive-Compulsive Scale, Self-Report (Y-BOCS-SR)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient Health Questionnaire (PHQ-9)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Aino Mattila, Tampere University Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 5월 25일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .