Neurobiological Markers of Treatment Response for Anxiety and OCD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Panic Disorder Severity Scale (PDSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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"
排除标准
- •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)
结局指标
主要结局
Panic Disorder Severity Scale (PDSS)
时间窗: three months after treatment
Symptom severity of panic disorder
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: three months after treatment
Symptom severity of obsessive-compulsive disorder
Liebowitz Social Anxiety Scale (LSAS)
时间窗: three months after treatment
Symptom severity of social anxiety disorder
次要结局
- DNA Methylation(three months after treatment)
- Magnetic Resonance Imaging(three months after treatment)