Neurobiological Markers of Treatment Response for Anxiety and OCD

NCT05663489 | Recruiting

• 1 other identifier: BCBP-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder; Social Anxiety Disorder; Panic Disorder

Keywords

MRI; epigenetics; genetics

Outcome Measures

Primary Outcomes (9)

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Symptom severity of obsessive-compulsive disorder

  Before treatment

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Symptom severity of obsessive-compulsive disorder

  approximately 10 days after treatment

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Symptom severity of obsessive-compulsive disorder

  three months after treatment

• Panic Disorder Severity Scale (PDSS)

  Symptom severity of panic disorder

  Before treatment

• Panic Disorder Severity Scale (PDSS)

  Symptom severity of panic disorder

  approximately 10 days after treatment

• Panic Disorder Severity Scale (PDSS)

  Symptom severity of panic disorder

  three months after treatment

• Liebowitz Social Anxiety Scale (LSAS)

  Symptom severity of social anxiety disorder

  Before treatment

• Liebowitz Social Anxiety Scale (LSAS)

  Symptom severity of social anxiety disorder

  approximately 10 days after treatment

• Liebowitz Social Anxiety Scale (LSAS)

  Symptom severity of social anxiety disorder

  three months after treatment

Secondary Outcomes (6)

• DNA Methylation

  Before treatment

• DNA Methylation

  approximately 10 days after treatment

• DNA Methylation

  three months after treatment

• Magnetic Resonance Imaging

  Before treatment

• Magnetic Resonance Imaging

  approximately 10 days after treatment

Study Arms (2)

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)

For MRI substudy: Healthy controls

Healthy controls demographically matched to the patient group on age, sex and years of education

Interventions

Bergen 4-Day Treatment (B4DT) BEHAVIORAL

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

Patients with obsessive-compulsive, social anxiety or panic disorder

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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"

You may not qualify if:

• Suicidal, ongoing mania, primary eating disorder, intellectual disability, ongoing psychosis, ongoing substance abuse
• For MRI substudy:
• \- For the healthy controls, no previous or current psychiatric disorders as detected by the Mini International Neuropsychiatric Interview (MINI)
• \- MRI incompatibility (e.g. pregnancy, metal implants)

Sponsors & Collaborators

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

Study Sites (1)

Bergen Center for Brain Plasticity

Bergen, Vestland, 5009, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Phobia, Social; Panic Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Bjarne Hansen, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjarne Hansen, PhD

CONTACT

+4792090765; bjarne.kristian.aaslie.hansen@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: March 23, 2018
• Primary Completion: August 1, 2024
• Study Completion (Estimated): December 11, 2027
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)