ISRCTN ISRCTN15432513
DOI https://doi.org/10.1186/ISRCTN15432513
Valtion tutkimusrahoitus (State's research funding) grant number TYH2024337
Sponsor Helsinki University Hospital
Funder Valtion tutkimusrahoitus
Submission date
28/04/2026
Registration date
29/04/2026
Last edited
28/04/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Obsessive compulsive disorder (OCD) has ranked among 10 most debilitating disorders by WHO, affecting 2-3% of population, having early onset and substantial psychiatric comorbidity. Bergen 4 Day Treatment (B4DT) is a concentrated exposure treatment (cET) developed to treat OCD and has proven to be highly acceptable and effective. However, only a few studies have been conducted to assess the long-term effects of B4DT.

The aim of the study is to investigate the persistence of B4DT treatment results among the patients who have received B4DT in HUS in 2022-2026. In addition to OCD symptom severity, severity of depressive and anxiety symptoms, psychological distress and the overall functioning and wellbeing of the patients will be assessed.

Who can participate?
Adult patients aged 18 years and over who have received B4DT for their OCD in HUS in 2022-2026.

What does the study involve?
Participants will complete electronic questionnaires to measure their OCD, depressive and anxiety symptoms as well as psychological distress, overall wellbeing and functioning , and undergo a structured interview. Additional data such as information about participants' health care use and treatments will be collected from electronic health registry (EHR) data and HUS data pool.

What are the possible benefits and risks of participating?
Availability of effective evidence based treatments for OCD is very limited in Finland. This study aims to evaluate the implementation and long-term outcomes of this new form of effective treatment, B4DT. Participation or non-participation will have no impact on other treatment modalities or possibilities for the patients. The possible risks associated with interview and questionnaires included in this study are small. The interviewers are trained research assistants or psychologists with sufficient consultation support, and who are able to refer the interviewee to appropriate healthcare services if needed.

Where is the study run from?
The study will be conducted in Helsinki University Hospital (HUS), Finalnd.

When is the study starting and how long is it expected to run for?
The study is set to begin in May 2026, with recruitment, interviews and questionnaired expected to continue until the end of 2026

Who is funding the study?
The study is primarily funded by State’s research funding (Valtion tutkimusrahoitus). Additional funding
may be provided by HUS (Helsinki University Hospital) and other research foundations.

Who is the main contact?
Professor Suoma E. Saarni, MD, PhD, who serves as the principal investigator, is based at HUS and Tampere University, suoma.saarni@hus.fi

Contact information

Prof Suoma Saarni
Public, Scientific, Principal investigator

HUS Psychiatry, Välskärinkatu 12
Helsinki
00029
Finland
Helsinki
00029
Finland

ORCiD logoORCID ID 0000-0003-3555-9958
Phone +358407614711
Email suoma.saarni@hus.fi

Study information

Primary study designObservational
Observational study designCase series
Scientific titleBergen 4-day treatment (B4DT): A follow-up study about the persistence of the therapeutic effects after the intervention
Study acronymB4Three
Study objectives The aim of study is to investigate the persistence of B4DT treatment results among the patients who have received B4DT in HUS in 2022-2025. In addition to OCD symptom severity, severity of depressive and anxiety symptoms, the overall functioning and wellbeing of the patients (e.g. the employment status, absenteeism, social functioning) will be assessed.
Ethics approval(s)

Approved 13/08/2025, Helsinki University Hospital (HUS) Regional Committee on Medical Research Ethics (PO BOX 705, Helsinki, 00029, Finland; +358 9471 71607; eettinen.toimikunta@hus.fi), ref: HUS/7582/2025

Health condition(s) or problem(s) studiedObsessive-Compulsive Disorder (OCD)
InterventionBergen 4 Day Treatment (B4DT) is a psychotherapeutic treatment based on intensive exposure and response prevention and targeted at OCD.

All patients who have participated in B4DT for OCD in HUS in 2022-2025 will be contacted and offered an opportunity to participate in the study.

Participants will complete electronic questionnaires to measure their OCD symptoms as well as overall mental wellbeing, and undergo a structured interview by a psychologist.

Additional data, such as information about participants' psychiatric treatments, will be collected from electronic health registry (EHR) data and the HUS data pool.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Within-individual change in OCD severity measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and Obsessive Compulsive Inventory – Revised (OCI-R) at baseline (clinical records) and at one time point at follow-up
Key secondary outcome measure(s)
  1. Within-individual change in OCD severity measured using Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and Obsessive Compulsive Inventory – Revised (OCI-R) at 10 days (clinical records) and 3 months (clinical records) and at one time point at follow-up
  2. Symptom levels of depression, anxiety and psychological distress measured using the Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Clinical Outcomes in Routine Evaluation 10 (CORE-10) at 10 days (clinical records) and 3 months (clinical records) and at one time point at follow-up
  3. Mental wellbeing, functionality level, Health-related Quality of Life, measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Emotional and Psychological Outcome (EPO-1) and Work and Social Adjustment Scale (WSAS), Health Related Quality of Life (EQ-5D) at one time point at follow-up
Completion date31/12/2030

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit120 Years
SexAll
Target sample size at registration75
Key inclusion criteriaAll patients that have participated in B4DT for OCD in HUS in Jan 2022-Dec 2025 will be contacted and offered an opportunity to participate in the study.
Key exclusion criteriaNot meeting the key inclusion criteria.
Date of first enrolment18/05/2026
Date of final enrolment28/02/2027

Locations

Countries of recruitment

  • Finland

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan

Editorial Notes

28/04/2026: Study’s existence confirmed by the Helsinki University Hospital (HUS) Regional Medical Research Ethics Committee, Finland.