Four-day intensive treatment for obsessive-compulsive disorder - a feasibility study

ISRCTN	ISRCTN35242159
DOI	https://doi.org/10.1186/ISRCTN35242159

Submission date: 09/06/2022
Registration date: 10/06/2022
Last edited: 10/06/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Obsessive compulsive disorder (OCD) is a common mental health condition where a person has obsessive thoughts and compulsive behaviours. OCD can affect men, women and children. Some people start having symptoms early, often around puberty, but it usually starts during early adulthood.
Bergen 4 Day Treatment (B4DT) is a concentrated exposure treatment (cET) developed to treat OCD. It has proven to be highly acceptable and effective in other settings. In this feasibility study we investigate the implementation, feasibility, and preliminary outcomes of B4DT treatment in HUS psychiatry settings in 5-7 therapy groups.

Who can participate?
Adult patients who have been diagnosed with obsessive compulsive disorder.

What does the study involve?
The study involves a pre-screening interview, the actual intensive treatment period in four consecutive days in HUS outpatient clinic within a group of 3-6 patients and at least the same number of therapists, and a follow-up at 10 days and at 3 months after the treatment.

What are the possible benefits and risks of participating?
Based on previous research results, we assume the Bergen 4 Day Treatment model will be an effective and safe treatment that is well suited for the Finnish treatment environment. Participating in the study may be beneficial for you and ameliorate your OCD symptoms.
As the exact same treatment has been in use in other Scandinavian countries for some years and shown to be safe and effective, it is unlikely to have any unexpected adverse events.

Where is the study run from?
Helsinki University Hospital (Finland)

When is the study starting and how long is it expected to run for?
November 2021 to April 2023

Who is funding the study?
Helsinki University Hospital (Finland)

Who is the main contact?
Suoma Saarni, PhD, suoma.saarni@hus.fi

Contact information

Dr Suoma Saarni
Principal Investigator

HUS Brain Center
Department of Psychiatry
It-psychiatry and psychosocial treatments
P.o.Box 590
Helsinki
00029 HUS
Finland

ORCID ID	0000-0003-3555-9958
Phone	+358 9 4711
Email	suoma.saarni@hus.fi

Study information

Study design	Observational feasibility study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	Bergen 4 Day Treatment (B4DT) for Obsessive-Compulsive Disorder (OCD) – an observational feasibility study
Study acronym	B4DT-HKI-I
Study hypothesis	We investigate the implementation, feasibility, and preliminary outcomes of B4DT treatment in HUS psychiatry settings in Finland
Ethics approval(s)	Approved 06/04/2022, Helsinki and Uusimaa Hospital District (HUS) Ethics Committee (PO BOX 705, 00029, Finland; +358 40 617 5386; mirka.salin@hus.fi), ref: HUS/1085/2022
Condition	Obsessive-compulsive disorder
Intervention	The patients will receive a concentrated exposure treatment (cET) conducted in four consecutive days in HUS psychiatry outpatient clinic according to Bergen four day treatment for OCD (B4DT) manual. After ten days and three weeks after treatment, patients are offered a short follow-up session to discuss their experiences during and after the active treatment period.
Intervention type	Behavioural
Primary outcome measure	Within-individual decline in Y-BOCS score before the intervention vs. after the treatment and at three months.
Secondary outcome measures	Measured before the intervention vs. after the treatment and at three months. 1. OCD symptoms measured with OCI-R and DOCS-SF 2. Depression (PHQ-9) 3. Anxiety (GAD-7) 4. Sleeping problems (BIS) 5. Functionality (WSAS) 6. Well-being (WEMWBS) 7. Client satisfaction (CSQ-8)
Overall study start date	09/11/2021
Overall study end date	20/04/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	30
Participant inclusion criteria	DSM-5 Obsessive-compulsive disorder
Participant exclusion criteria	1. Concurrent psychotic disorder 2. Substance use disorder 3. Imminent risk of suicide 4. Congenital disability 5. New antidepressant or antipsychotic pharmacotherapy trial started within the last six weeks 6. Use of benzodiazepines is allowed only for insomnia 7. Ongoing other evidence-based psychotherapy for OCD
Recruitment start date	01/05/2022
Recruitment end date	31/12/2022

Locations

Countries of recruitment

Finland

Study participating centre

Helsinki University Hospital

HUS Brain Center
Department of Psychiatry
P.o.Box 590
Helsinki
00029 HUS
Finland

Sponsor information

Helsinki University Hospital
Hospital/treatment centre

HUS Brain Center
Department of Psychiatry
P.o.Box 590
Helsinki
00029 HUS
Finland

Phone	+350 9 4711
Email	erkki.isometsa@helsinki.fi
Website	https://www.hus.fi/en
"ROR"	https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Helsinki University Hospital

No information available

Results and Publications

Intention to publish date	01/12/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Intended to be published in a peer-reviewed scientific journal
IPD sharing plan	The data will be held by the Helsinki and Uusimaa Hospital District, and it will not be available because of limitations caused by the Finnish data protection legislation, content of consent requested, and research permit.

Editorial Notes

10/06/2022: Trial's existence confirmed by HUS ethics committee