Neurobiological Markers of Treatment Response for Anxiety and OCD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorHaukeland University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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"
Disqualifiers
Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bergen 4-Day Treatment (B4DT)
BehavioralA concentrated and exposure-based psychological treatment over four consecutive days
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Patients with obsessive-compulsive, social anxiety or panic disorder1 intervention
Group B: For MRI substudy: Healthy controls0 interventions
Trial outcomes
Primary outcomes
1
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Time frame
Before treatment2
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Time frame
approximately 10 days after treatment3
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Time frame
three months after treatment4
Panic Disorder Severity Scale (PDSS)
Symptom severity of panic disorder
Time frame
Before treatmentSecondary outcomes
1
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
Time frame
Before treatment2
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
Time frame
approximately 10 days after treatment3
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
Time frame
three months after treatment4
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
Time frame
Before treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Haukeland University Hospital
Lead sponsor
University of Oslo
Collaborator
Amsterdam UMC, location VUmc
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Harvard Medical School (HMS and HSDM)
Collaborator
University of Bergen
Collaborator
Oslo University Hospital
Collaborator
Source ClinicalTrials.gov