The Impact of CBT on Shock-Potentiated Neural Circuity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- 'Aversive amplification circuit' connectivity
研究概览
简要总结
This study will aim to test whether specific neural circuitry changes, proposed on the basis of a neurocognitive model of anxiety, are a mechanism of action for Cognitive Behavioural Therapy (CBT) interventions. This study aims to provide a theoretical model of the neurobiological mechanisms of CBT's therapeutic effect, where there currently is none, and potentially allow for more targeted/specific approaches to anxiety disorders following the identification of key CBT mechanisms. The ultimate aim is to improve the efficacy of CBT, and more generally, psychological interventions for anxiety disorders.
详细描述
To test the hypothesis that the neural circuitry of the amygdala and prefrontal cortex will respond to CBT, the impact of a course of CBT on cortical-subcortical circuitry will be tested via a case-control study in individuals entering Improving Access to Psychological Therapies (IAPT) services (IAPT step 3; i.e., full CBT) for anxiety disorders and individuals in waiting lists. This design leverages the naturalistic waiting times in the clinical service and does not interfere with treatment as usual. Measures of brain region-specific connectivity and emotion-related behavioural performance will be assessed through testing sessions at the University College London (UCL) Institute of Cognitive Neuroscience and the Birkbeck-UCL Centre for NeuroImaging (BUCNI), involving computerised cognitive/psychological tasks and functional magnetic resonance imaging (fMRI).
The aims are to:
- test whether this circuit responds to a course of CBT, by demonstrating disengagement of the circuit following CBT
- relate this change in circuit function to behaviour through cognitive measures of emotional processing
- explore the neurobiological features that distinguish patients who respond to CBT and those who do not
- compare the data from this study to another on-going study assessing the impact of pharmacological interventions for anxiety, allowing for the comparison of neurobiological mechanisms of psychological vs. pharmacological treatments in anxiety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in IAPT Step 3 (high intensity service)
- •Score of or above 8 on the GAD-7 (indicating moderate anxiety on a standard scale of anxiety; Spitzer et al., 2006)
- •Willing and able to provide written consent
排除标准
- •Score above 22 on the GAD-7
- •Past/present psychotic disorder, bipolar disorder/mania or alcohol/substance use disorder (outside a comorbid psychiatric episode)
- •History of medical illness that may impair cognitive function (e.g. serious head injury, endocrine disorder)
- •Current psychotropic pharmacological intervention (e.g. SSRIs) or use within 3 months
- •MRI contraindications such as pacemaker, aneurysm clip, cochlear implant, neurostimulator, IUD, shrapnel, metal fragments in eye, weight of above 250lbs or claustrophobia
- •Females who are pregnant, planning pregnancy, or breastfeeding
结局指标
主要结局
'Aversive amplification circuit' connectivity
时间窗: Day 0, up to 12 weeks (post-CBT or matched time on waiting list)
The engagement of the neural circuit of the amygdala, cingulate cortex and prefrontal cortex will be measured via an fMRI analysis technique called a psychophysiological interactions (PPI) analysis. PPI analysis concerns behaviour-specific increases in the relationship across regional brain activity - this means that it can allow one to assess whether two regions (a priori selected ROIs) show increased connectivity during a specific context or behaviour, suggesting a behaviour-specific increase in transfer of information. The output of this analysis will take form of a continuous beta weight - an index of connectivity across two brain regions (amygdala and medial prefrontal cortex), which represents the primary outcome of the study.
次要结局
- Cognitive task performance: Go/no-go task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Cognitive task performance: Visual affective bias task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Regional activations during neuroimaging task: Facial emotional processing task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Regional activations during neuroimaging task: Visual affective bias task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measures: Beck's Depression Inventory (BDI)(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Cognitive task performance: Loss/risk aversion task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Cognitive task performance: Facial emotional processing task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measures: Catastrophizing questionnaire(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measures: Daily Stress Inventory (DSI)(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measures: Eysenck Impulsiveness Scale(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measures: Patient Health Questionnaire (PHQ-9)(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Cognitive task performance: Emotional face recognition task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Regional activations during neuroimaging task: Emotional face recognition task(Day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measure: Generalised Anxiety Disorder Scale (GAD-7)(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measure: State Trait Anxiety Inventory (STAI)(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))
- Clinical symptom measures: Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS)(Screening, day 0, up to 12 weeks (post-CBT or matched time on waiting list))