Neurobiological Markers of Treatment Response for Anxiety and OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Neurobiological Markers of Treatment Response for Anxiety and OCD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663489
• Other study ID #: BCBP-1
• Status: Recruiting
• Start date: March 23, 2018
• Est. completion date: December 11, 2027

Study information

• Verified date: December 2022
• Source: Haukeland University Hospital
• Contact: Bjarne Hansen, PhD
• Phone: +4792090765
• Email: bjarne.kristian.aaslie.hansen[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 11, 2027
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Obsessive-Compulsive Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Bergen 4-Day Treatment (B4DT)
A concentrated and exposure-based psychological treatment over four consecutive days

Locations

Country	Name	City	State
Norway	Bergen Center for Brain Plasticity	Bergen	Vestland

Sponsors (7)

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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	Symptom severity of obsessive-compulsive disorder	Before treatment
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	Symptom severity of obsessive-compulsive disorder	approximately 10 days after treatment
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	Symptom severity of obsessive-compulsive disorder	three months after treatment
Primary	Panic Disorder Severity Scale (PDSS)	Symptom severity of panic disorder	Before treatment
Primary	Panic Disorder Severity Scale (PDSS)	Symptom severity of panic disorder	approximately 10 days after treatment
Primary	Panic Disorder Severity Scale (PDSS)	Symptom severity of panic disorder	three months after treatment
Primary	Liebowitz Social Anxiety Scale (LSAS)	Symptom severity of social anxiety disorder	Before treatment
Primary	Liebowitz Social Anxiety Scale (LSAS)	Symptom severity of social anxiety disorder	approximately 10 days after treatment
Primary	Liebowitz Social Anxiety Scale (LSAS)	Symptom severity of social anxiety disorder	three months after treatment
Secondary	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	Before treatment
Secondary	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	approximately 10 days after treatment
Secondary	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	three months after treatment
Secondary	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	Before treatment
Secondary	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	approximately 10 days after treatment
Secondary	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	three months after treatment