Bergen Center for Brain Plasticity
Bergen, Vestland, 5009, Norway
Location status: Recruiting
NCT Number: NCT05663489
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.
Interested in participating?
Request Info16 year and older
All sexes
Observational
Bergen, Vestland, 5009, Norway
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For MRI substudy:
Inclusion criteria
Exclusion criteria
A concentrated and exposure-based psychological treatment over four consecutive days
Time frame: Before treatment
Symptom severity of obsessive-compulsive disorder
Time frame: approximately 10 days after treatment
Symptom severity of obsessive-compulsive disorder
Time frame: three months after treatment
Symptom severity of obsessive-compulsive disorder
Time frame: Before treatment
Symptom severity of panic disorder
Time frame: approximately 10 days after treatment
Symptom severity of panic disorder
Time frame: three months after treatment
Symptom severity of panic disorder
Time frame: Before treatment
Symptom severity of social anxiety disorder
Time frame: approximately 10 days after treatment
Symptom severity of social anxiety disorder
Time frame: three months after treatment
Symptom severity of social anxiety disorder
Time frame: Before treatment
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Haukeland University Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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