Obsessive-Compulsive DisorderNCT05663489
Neurobiological Markers of Treatment Response for Anxiety and OCD
An observational study of Obsessive-Compulsive Disorder and Social Anxiety Disorder, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Obsessive-compulsive disorder (OCD) and anxiety disorders are common and debilitating conditions which are often chronic when treatment is not provided. International guidelines recommend cognitive behavioral therapy (CBT) as the first-line treatment, and research has shown that CBT can be delivered over a… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder, Social Anxiety Disorder, Panic Disorder
- What is being tested?
- Bergen 4-Day Treatment (B4DT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 23 Mar 2018to 11 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study includes patients with OCD, panic disorder or social anxiety disorder which will receive the Bergen 4-Day Treatment (B4DT) in Norway. Healthy controls are also recruited for the MRI substudy
Who may be able to join
- Diagnosed with obsessive-compulsive disorder, panic disorder or social anxiety disorder using DSM-5 criteria
- Referred to National Clinic for 4-Day Treatment, Haukeland University Hospital, Bergen, Norway
- Consented to participate in the "Kvalitetsregister for konsentrerte behandlingsformat"
- For the healthy controls, no previous or current psychiatric disorders as detected by the Mini International Neuropsychiatric Interview (MINI)
Who cannot join
- Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse
- For MRI substudy:
- MRI incompatibility (e.g. pregnancy, metal implants)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Bergen Center for Brain Plasticity
Bergen, Vestland, 5009
Bjarne Hansen, PhD, +4792090765, bjarne.kristian.aaslie.hansen@helse-bergen.no
About this study
Obsessive-compulsive disorder (OCD) and anxiety disorders are common and debilitating conditions which are often chronic when treatment is not provided. International guidelines recommend cognitive behavioral therapy (CBT) as the first-line treatment, and research has shown that CBT can be delivered over a concentrated period of time. The Bergen 4-Day Treatment (B4DT) is an exposure-based treatment which is delivered over four consecutive days. B4DT has been shown to induce rapid and long-lasting remission in around 70% of patients. This provides a platform for studying psychological and neurobiological changes associated with treatment response and non-response. The present study will investigate longitudinal changes in psychological measures and DNA methylation in patients who receive the B4DT, as well as a subset will also undergo multimodal brain imaging.
Read the detailed description
The primary study will include 500 OCD patients who will receive the B4DT. Symptom severity will be prospectively measured before treatment, approximately 10 days after treatment and three months after treatment. Saliva samples will be collected for later extraction of DNA methylation during the first day of treatment, the last day of treatment, and three months after treatment. A substudy will use multimodal magnetic resonance imaging (MRI) before treatment, approximately 10 days after treatment and three months after treatment. The substudy will also 100 patients with social anxiety disorder or panic disorder for DNA methylation and MRI, as well as 50 healthy controls for MRI. Clinical data will be collected from a consent-based quality register ("Kvalitetsregister for konsentrerte behandlingsformat").
The aim of the study is to investigate changes in DNA methylation as well as functional and structural brain networks that occur in patients undergoing B4DT, and to correlate these changes with immediate and long-term response to treatment.
- Being tested
- Bergen 4-Day Treatment (B4DT)
- Keywords
- MRI, epigenetics, genetics
- Medical subject headings
- Obsessive-Compulsive Disorder, Phobia, Social, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bergen 4-Day Treatment (B4DT)Behavioural
A concentrated and exposure-based psychological treatment over four consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Patients with obsessive-compulsive, social anxiety or panic disorder | Patients with obsessive-compulsive disorder. The MRI substudy will also include patients with social anxiety or panic disorder Receives: Behavioral: Bergen 4-Day Treatment (B4DT) | |
| For MRI substudy: Healthy controls | Healthy controls demographically matched to the patient group on age, sex and years of education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Measured: Before treatment
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Measured: approximately 10 days after treatment
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Measured: three months after treatment
Panic Disorder Severity Scale (PDSS)
Symptom severity of panic disorder
Measured: Before treatment
Panic Disorder Severity Scale (PDSS)
Symptom severity of panic disorder
Measured: approximately 10 days after treatment
Panic Disorder Severity Scale (PDSS)
Symptom severity of panic disorder
Measured: three months after treatment
Liebowitz Social Anxiety Scale (LSAS)
Symptom severity of social anxiety disorder
Measured: Before treatment
Liebowitz Social Anxiety Scale (LSAS)
Symptom severity of social anxiety disorder
Measured: approximately 10 days after treatment
Liebowitz Social Anxiety Scale (LSAS)
Symptom severity of social anxiety disorder
Measured: three months after treatment
Secondary outcomes (6)
DNA Methylation
Samples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system
Measured: Before treatment
DNA Methylation
Samples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system
Measured: approximately 10 days after treatment
DNA Methylation
Samples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system
Measured: three months after treatment
Magnetic Resonance Imaging
Brain functional and structural MRI will be collected for a subset of 100 OCD and 100 anxiety disorder patients as well as 50 healthy controls
Measured: Before treatment
Magnetic Resonance Imaging
Brain functional and structural MRI will be collected for a subset of 100 OCD and 100 anxiety disorder patients as well as 50 healthy controls
Measured: approximately 10 days after treatment
Magnetic Resonance Imaging
Brain functional and structural MRI will be collected for a subset of 100 OCD and 100 anxiety disorder patients as well as 50 healthy controls
Measured: three months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start23 Mar 2018
- Primary completion1 Aug 2024 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Amsterdam UMC, location VUmc, University of North Carolina, Chapel Hill, Harvard Medical School (HMS and HSDM), University of Bergen, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Bjarne Hansen, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663489
- Sponsor's protocol ID
- BCBP-1
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Markers of Treatment Response for Anxiety and OCD
- ClinicalTrials.gov ID
- NCT05663489
- Acronym / sponsor ID
- BCBP-1
- Keywords
- MRI, epigenetics, genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Amsterdam UMC, location VUmc, University of North Carolina, Chapel Hill, Harvard Medical School (HMS and HSDM), University of Bergen, Oslo University Hospital
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 11 Dec 2027 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obsessive-compulsive disorder (OCD) and anxiety disorders are common and debilitating conditions which are often chronic when treatment is not provided. International guidelines recommend cognitive behavioral therapy (CBT) as the first-line treatment, and research has shown that CBT can be delivered over a concentrated period of time. The Bergen 4-Day Treatment (B4DT) is an exposure-based treatment which is delivered over four consecutive days. B4DT has been shown to induce rapid and long-lasting remission in around 70% of patients. This provides a platform for studying psychological and neurobiological changes associated with treatment response and non-response. The present study will investigate longitudinal changes in psychological measures and DNA methylation in patients who receive the B4DT, as well as a subset will also undergo multimodal brain imaging.
Detailed description
The primary study will include 500 OCD patients who will receive the B4DT. Symptom severity will be prospectively measured before treatment, approximately 10 days after treatment and three months after treatment. Saliva samples will be collected for later extraction of DNA methylation during the first day of treatment, the last day of treatment, and three months after treatment. A substudy will use multimodal magnetic resonance imaging (MRI) before treatment, approximately 10 days after treatment and three months after treatment. The substudy will also 100 patients with social anxiety disorder or panic disorder for DNA methylation and MRI, as well as 50 healthy controls for MRI. Clinical data will be collected from a consent-based quality register ("Kvalitetsregister for konsentrerte behandlingsformat").
The aim of the study is to investigate changes in DNA methylation as well as functional and structural brain networks that occur in patients undergoing B4DT, and to correlate these changes with immediate and long-term response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with obsessive-compulsive, social anxiety or panic disorder | – | Behavioral: Bergen 4-Day Treatment (B4DT)Patients with obsessive-compulsive disorder. The MRI substudy will also include patients with social anxiety or panic disorder |
| For MRI substudy: Healthy controls | – | –Healthy controls demographically matched to the patient group on age, sex and years of education |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study includes patients with OCD, panic disorder or social anxiety disorder which will receive the Bergen 4-Day Treatment (B4DT) in Norway. Healthy controls are also recruited for the MRI substudy
Key inclusion criteria (4 listed)
- Diagnosed with obsessive-compulsive disorder, panic disorder or social anxiety disorder using DSM-5 criteria
- Referred to National Clinic for 4-Day Treatment, Haukeland University Hospital, Bergen, Norway
- Consented to participate in the "Kvalitetsregister for konsentrerte behandlingsformat"
- For the healthy controls, no previous or current psychiatric disorders as detected by the Mini International Neuropsychiatric Interview (MINI)
Key exclusion criteria (3 listed)
- Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse
- MRI incompatibility (e.g. pregnancy, metal implants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bergen 4-Day Treatment (B4DT)A concentrated and exposure-based psychological treatment over four consecutive days | Behavioural | Patients with obsessive-compulsive, social anxiety or panic disorder |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: Before treatment
Symptom severity of obsessive-compulsive disorder
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: approximately 10 days after treatment
Symptom severity of obsessive-compulsive disorder
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: three months after treatment
Symptom severity of obsessive-compulsive disorder
Panic Disorder Severity Scale (PDSS)
Time frame: Before treatment
Symptom severity of panic disorder
Panic Disorder Severity Scale (PDSS)
Time frame: approximately 10 days after treatment
Symptom severity of panic disorder
Panic Disorder Severity Scale (PDSS)
Time frame: three months after treatment
Symptom severity of panic disorder
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Before treatment
Symptom severity of social anxiety disorder
Liebowitz Social Anxiety Scale (LSAS)
Time frame: approximately 10 days after treatment
Symptom severity of social anxiety disorder
Liebowitz Social Anxiety Scale (LSAS)
Time frame: three months after treatment
Symptom severity of social anxiety disorder
6 secondary outcomes
DNA Methylation
Time frame: Before treatment
DNA Methylation
Time frame: approximately 10 days after treatment
DNA Methylation
Time frame: three months after treatment
Magnetic Resonance Imaging
Time frame: Before treatment
Magnetic Resonance Imaging
Time frame: approximately 10 days after treatment
Magnetic Resonance Imaging
Time frame: three months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bjarne Hansen, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder and Social Anxiety Disorder, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bjarne Hansen, PhD (+4792090765, bjarne.kristian.aaslie.hansen@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Before treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.