Neurobiological Markers of Treatment Response for Anxiety and OCD

• Sponsor: Haukeland University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05663489
• Collaborator: University of Oslo (Other), Amsterdam UMC, location VUmc (Other), University of North Carolina, Chapel Hill (Other), Harvard Medical School (HMS and HSDM) (Other), University of Bergen (Other), Oslo University Hospital (Other)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 116.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder; Social Anxiety Disorder; Panic Disorder	Behavioral: Bergen 4-Day Treatment (B4DT)

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Neurobiological Markers of Treatment Response for Anxiety and OCD
• Actual Study Start Date: Mar 23, 2018
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Dec 11, 2027

Arms and Interventions

Arm	Intervention/Treatment
Patients with obsessive-compulsive, social anxiety or panic disorder Patients with obsessive-compulsive disorder. The MRI substudy will also include patients with social anxiety or panic disorder	Behavioral: Bergen 4-Day Treatment (B4DT); A concentrated and exposure-based psychological treatment over four consecutive days
For MRI substudy: Healthy controls Healthy controls demographically matched to the patient group on age, sex and years of education

Outcome Measures

Primary Outcome Measures

1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Before treatment]

   Symptom severity of obsessive-compulsive disorder

2. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [approximately 10 days after treatment]

   Symptom severity of obsessive-compulsive disorder

3. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [three months after treatment]

   Symptom severity of obsessive-compulsive disorder

4. Panic Disorder Severity Scale (PDSS) [Before treatment]

   Symptom severity of panic disorder

5. Panic Disorder Severity Scale (PDSS) [approximately 10 days after treatment]

   Symptom severity of panic disorder

6. Panic Disorder Severity Scale (PDSS) [three months after treatment]

   Symptom severity of panic disorder

7. Liebowitz Social Anxiety Scale (LSAS) [Before treatment]

   Symptom severity of social anxiety disorder

8. Liebowitz Social Anxiety Scale (LSAS) [approximately 10 days after treatment]

   Symptom severity of social anxiety disorder

9. Liebowitz Social Anxiety Scale (LSAS) [three months after treatment]

   Symptom severity of social anxiety disorder

Secondary Outcome Measures

1. DNA Methylation [Before treatment]

   Samples of saliva will be collected for genome-wide methylation and profiling will be carried out using the Illumina Infinium MethylationEPIC BeadChip system

2. DNA Methylation [approximately 10 days 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

3. 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

4. Magnetic Resonance Imaging [Before 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

5. Magnetic Resonance Imaging [approximately 10 days 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Exclusion Criteria:

• MRI incompatibility (e.g. pregnancy, metal implants)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bergen Center for Brain Plasticity	Bergen	Vestland	Norway	5009

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Bjarne Hansen, PhD, Haukeland University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT05663489
• Other Study ID Numbers: BCBP-1
• First Posted: Dec 23, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haukeland University Hospital: MRI; epigenetics; genetics
• Additional relevant MeSH terms: Disease; Anxiety Disorders; Obsessive-Compulsive Disorder; Panic Disorder; Phobia, Social

Study Results

No Results Posted as of Dec 23, 2022