MedDataX Logo

Neurobiological Markers of Treatment Response for Anxiety and OCD

NCT ID: NCT05663489

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-23

Study Completion Date

2027-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obsessive-Compulsive Disorder Social Anxiety Disorder Panic Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

MRI epigenetics genetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Bergen 4-Day Treatment (B4DT)

Intervention Type BEHAVIORAL

A concentrated and exposure-based psychological treatment over four consecutive days

For MRI substudy: Healthy controls

Healthy controls demographically matched to the patient group on age, sex and years of education

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bergen 4-Day Treatment (B4DT)

A concentrated and exposure-based psychological treatment over four consecutive days

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse

For MRI substudy:


\- MRI incompatibility (e.g. pregnancy, metal implants)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bjarne Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bergen Center for Brain Plasticity

Bergen, Vestland, Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bjarne Hansen, PhD

Role: CONTACT

Phone: +4792090765

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bjarne Hansen, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BCBP-1

Identifier Type: -

Identifier Source: org_study_id