Investigating brain and genetic changes in anxiety and OCD treatment
Neurobiological Markers of Treatment Response for Anxiety and OCD
This study is testing how a special 4-day therapy for OCD and other anxiety disorders affects both mental health and brain changes in patients, while also looking at their DNA.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT05663489 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with obsessive-compulsive disorder (OCD), social anxiety disorder, and panic disorder undergoing the Bergen 4-Day Treatment (B4DT), an intensive exposure-based therapy. The study aims to assess psychological and neurobiological changes associated with treatment response by measuring symptom severity and collecting saliva samples for DNA methylation analysis. Additionally, a subset of participants will undergo multimodal MRI to explore brain changes over time. The research will involve 500 OCD patients and a smaller group of patients with other anxiety disorders, alongside healthy controls for comparison.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with OCD, social anxiety disorder, or panic disorder who are referred for the B4DT at Haukeland University Hospital.
Not a fit: Patients with ongoing severe mental health issues, such as suicidal tendencies or psychosis, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of treatment responses in anxiety disorders, leading to more personalized and effective therapies.
How similar studies have performed: Previous studies have shown promising results with intensive CBT approaches like B4DT, indicating potential for success in this novel investigation of neurobiological markers.
Eligibility criteria
Show full inclusion / exclusion criteria
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" Exclusion Criteria: * Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse For MRI substudy: Inclusion Criteria: \- For the healthy controls, no previous or current psychiatric disorders as detected by the Mini International Neuropsychiatric Interview (MINI) Exclusion Criteria: \- MRI incompatibility (e.g. pregnancy, metal implants)
Where this trial is running
Bergen, Vestland
- Bergen Center for Brain Plasticity — Bergen, Vestland, Norway (Recruiting)
Study contacts
- Principal investigator: Bjarne Hansen, PhD — Haukeland University Hospital
- Study coordinator: Bjarne Hansen, PhD
- Email: bjarne.kristian.aaslie.hansen@helse-bergen.no
- Phone: +4792090765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.