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NCT Number: NCT05663489

Neurobiological Markers of Treatment Response for Anxiety and OCD

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergen Center for Brain Plasticity

Bergen, Vestland, 5009, Norway

Location status: Recruiting

Location contact

Bjarne Hansen, PhD

CONTACT

[email protected]

+4792090765

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bergen 4-Day Treatment (B4DT)

Behavioral

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

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: Before treatment

    Symptom severity of obsessive-compulsive disorder

  2. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: approximately 10 days after treatment

    Symptom severity of obsessive-compulsive disorder

  3. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: three months after treatment

    Symptom severity of obsessive-compulsive disorder

  4. Panic Disorder Severity Scale (PDSS)

    Time frame: Before treatment

    Symptom severity of panic disorder

  5. Panic Disorder Severity Scale (PDSS)

    Time frame: approximately 10 days after treatment

    Symptom severity of panic disorder

  6. Panic Disorder Severity Scale (PDSS)

    Time frame: three months after treatment

    Symptom severity of panic disorder

  7. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: Before treatment

    Symptom severity of social anxiety disorder

  8. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: approximately 10 days after treatment

    Symptom severity of social anxiety disorder

  9. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: three months after treatment

    Symptom severity of social anxiety disorder

Secondary outcomes

  1. DNA Methylation

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bjarne Hansen, PhD

CONTACT

[email protected]

+4792090765

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2027
First posted
Dec 23, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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