Clinical trial NCT05663489: Neurobiological Markers of Treatment Response for Anxiety and OCD
Official title: Neurobiological Markers of Treatment Response for Anxiety and OCD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obsessive-Compulsive Disorder
Social Anxiety Disorder
Panic Disorder
Keywords: MRI
epigenetics
genetics
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Amsterdam UMC, location VUmc
name: University of North Carolina, Chapel Hill
name: Harvard Medical School (HMS and HSDM)
name: University of Bergen
name: Oslo University Hospital
First posted: 2022-12-23
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

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.

Eligibility 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)

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Before treatment
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: approximately 10 days after treatment
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: three months after treatment
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: Before treatment
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: approximately 10 days after treatment
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: three months after treatment
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Before treatment
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: approximately 10 days after treatment
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: three months after treatment
Secondary outcomes:
measure: DNA Methylation
timeFrame: Before treatment
measure: DNA Methylation
timeFrame: approximately 10 days after treatment
measure: DNA Methylation
timeFrame: three months after treatment
measure: Magnetic Resonance Imaging
timeFrame: Before treatment
measure: Magnetic Resonance Imaging
timeFrame: approximately 10 days after treatment
measure: Magnetic Resonance Imaging
timeFrame: three months after treatment
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen Center for Brain Plasticity
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Bjarne Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: