An observational study in Obsessive-Compulsive Disorder, Social Anxiety Disorder and Panic Disorder, sponsored by Haukeland University Hospital. Recruiting at 1 site in Norway. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Haukeland University Hospital · Observational
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.
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.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 500 is above the median of 133 across 86 observational studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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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
Inclusion Criteria:
Exclusion Criteria:
For MRI substudy:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with obsessive-compulsive disorder. The MRI substudy will also include patients with social anxiety or panic disorder
Behavioral: Bergen 4-Day Treatment (B4DT)
Healthy controls demographically matched to the patient group on age, sex and years of education
A concentrated and exposure-based psychological treatment over four consecutive days
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Time frame: Before treatment
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Time frame: approximately 10 days after treatment
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Symptom severity of obsessive-compulsive disorder
Time frame: three months after treatment
Panic Disorder Severity Scale (PDSS)
Symptom severity of panic disorder
Time frame: Before treatment
Panic Disorder Severity Scale (PDSS)
Symptom severity of panic disorder
Time frame: approximately 10 days after treatment
Panic Disorder Severity Scale (PDSS)
Symptom severity of panic disorder
Time frame: three months after treatment
Liebowitz Social Anxiety Scale (LSAS)
Symptom severity of social anxiety disorder
Time frame: Before treatment
Liebowitz Social Anxiety Scale (LSAS)
Symptom severity of social anxiety disorder
Time frame: approximately 10 days after treatment
Liebowitz Social Anxiety Scale (LSAS)
Symptom severity of social anxiety disorder
Time frame: three months 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: three months after treatment
Plan to share: No
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