Neurobiological Markers of Treatment Response for Anxiety and OCD

Recruiting

• Conditions: Social Anxiety Disorder; Panic Disorder; Obsessive-Compulsive Disorder
• Interventions: Behavioral: Bergen 4-Day Treatment (B4DT)

• Registration Number: NCT05663489
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2018-03-23
• Status Verified: 2022-12
• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Last Update Submitted: 2022-12-15
• Study First Posted: 2022-12-23
• Last Update Posted: 2022-12-23
• Primary Completion: 2024-08-01
• Study Completion: 2027-12-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with obsessive-compulsive, social anxiety or panic disorder	Bergen 4-Day Treatment (B4DT)	Patients with obsessive-compulsive disorder. The MRI substudy will also include patients with social anxiety or panic disorder

Primary Outcome Measures

Name	Time	Method
Panic Disorder Severity Scale (PDSS)	three months after treatment	Symptom severity of panic disorder
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	three months after treatment	Symptom severity of obsessive-compulsive disorder
Liebowitz Social Anxiety Scale (LSAS)	three months after treatment	Symptom severity of social anxiety disorder

Secondary Outcome Measures

Name	Time	Method
DNA Methylation	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
Magnetic Resonance Imaging	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

Trial Locations

Locations (1)

Bergen Center for Brain Plasticity; 🇳🇴 Bergen, Vestland, Norway