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Neurobiological Markers of Treatment Response for Anxiety and OCD

Neurobiological Markers of Treatment Response for Anxiety and OCD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05663489
Enrollment
500
Registered
2022-12-23
Start date
2018-03-23
Completion date
2027-12-11
Last updated
2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder, Panic Disorder, Social Anxiety Disorder

Keywords

MRI, epigenetics, genetics

Brief summary

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

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.

Interventions

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

Sponsors

University of Oslo
CollaboratorOTHER
Amsterdam UMC, location VUmc
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
Harvard Medical School (HMS and HSDM)
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)Before treatmentSymptom severity of obsessive-compulsive disorder
Panic Disorder Severity Scale (PDSS)Before treatmentSymptom severity of panic disorder
Liebowitz Social Anxiety Scale (LSAS)Before treatmentSymptom severity of social anxiety disorder

Secondary

MeasureTime frameDescription
DNA MethylationBefore treatmentSamples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system
Magnetic Resonance ImagingBefore treatmentBrain functional and structural MRI will be collected for a subset of 100 OCD and 100 anxiety disorder patients as well as 50 healthy controls

Countries

Norway

Contacts

Primary ContactBjarne Hansen, PhD
bjarne.kristian.aaslie.hansen@helse-bergen.no+4792090765

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026