Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 4
- 主要终点
- Resting state functional connectivity within the default mode network
研究概览
简要总结
The purpose of this study is to determine whether neuroimaging-based markers of maladaptive self-focused processing are better predictors of treatment response to cognitive-behavioral therapy than behavioral markers.
详细描述
First, the investigators propose to identify the neural correlates of self-focused processing. The investigators will assess baseline resting state connectivity within the default network, as well as regional brain activation using a well-validated event-related fMRI task that manipulates self-focused processing in patients with body dysmorphic and socially anxious symptoms, compared to healthy controls. This clinical sample was selected because such patients display heightened self-focused attention, and sampling individuals across these symptom dimensions will ensure greater variability on this dimension of maladaptive self-focused processing. Second, the investigators will examine the neural correlates of self-focused processing as a predictor of treatment response. Neuroimaging data will be acquired from patients with body dysmorphic and socially anxious symptoms during two scan sessions, before and after 12 weeks of individual cognitive behavioral therapy, and compared with healthy controls scanned twice at a 12 week interval. Finally, the investigators will compare the prediction of treatment response between neural measures and behavioral measures of self-focused processing. The investigators will assess the behavioral correlates of self-focused processing using a self-reference effect paradigm, and assess their relation to treatment response. If the investigators hypotheses are borne out, the investigators will have new targets for treatment, a method to identify promising candidates for treatment, and sensitive surrogate markers of treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, age 18-45
- •For patients: treatment-seeking individuals presenting with at least moderate levels of social anxiety/body dysmorphic symptoms, and a score of at least 1 SD above the mean on the public self-consciousness scale of the Self-Consciousness Scale- Revised
- •For healthy controls only: no current or lifetime history of psychiatric disorders, and score of below 1 SD of mean on the SCS-R
- •Right-handed, as determined by the Handedness Inventory
- •Fluent in English, and willing to provide informed consent
排除标准
- •Positive MR screen
- •History of head injury, neurological disorder, or neurosurgical procedure
- •Active suicidal or homicidal ideation
- •Current or past manic/hypomanic episode or psychotic symptoms
- •Active alcohol and substance dependence (as assessed by the SCID-5-RV
- •Current use of psychotropic medications, except antidepressants taken at a stable dose for 2 weeks, to maximize generalizability of sample
- •Current CBT and/or formal mindfulness/meditation training
- •History of more than 10 sessions of CBT and formal mindfulness/meditation training
结局指标
主要结局
Resting state functional connectivity within the default mode network
时间窗: Baseline and 12 weeks later
Functional connectivity within the default mode network during resting state scan
Neural activation in the default mode network
时间窗: Baseline and 12 weeks later
Difference in regional brain activation in the default mode network in the Self vs. Other contrast (specifically in the medial prefrontal cortex, temporoparietal junction, posterior cingulate) during fMRI activation paradigm
Change from baseline clinical symptoms at 12 weeks
时间窗: Baseline and 12 weeks from baseline
Evidence of symptom improvement as determined by clinician-administered assessment of body dysmorphic and socially anxious symptoms
Response latencies during Self vs. Other conditions
时间窗: Baseline and 12 weeks later
Difference in average response latencies (in ms) during Self and Other conditions of a self-referential processing task
次要结局
- Word valence during Self vs. Other conditions(Baseline and 12 weeks later)
- Structural connectivity within the default mode network(Baseline and 12 weeks later)
研究者
Angela Fang
Assistant Professor of Psychology
Massachusetts General Hospital