Neural, Cognitive, and Clinical Effects of Prefrontal Cortex Stimulation to Enhance Psychotherapy in Depression: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory (BDI) score
研究概览
简要总结
Depression is a serious mental health problem that affects millions. Depression is usually treated using drugs and/or psychotherapy, but neither approach is successful for everyone, and some people do not respond to either. Therefore it is crucial that we continue to seek new methods for treating depression, and develop enhancements to existing treatments. In recent years, trials have documented improvements in depressive symptoms using noninvasive brain stimulation techniques, such as transcranial direct current stimulation, or tDCS. Our aim in this research is to investigate the effects of brain stimulation combined with psychological therapy in depression, an area that remains largely unexplored. Specifically, stimulation of the dorsolateral prefrontal cortex (DLPFC), a brain region known to work inefficiently in depression, has been shown to result in an improvement of depressive symptoms, as well as in the patient's 'cognitive control' abilities. Because 'cognitive control' processes, such as concentrating and ignoring distracting thoughts, are engaged during psychological therapies for depression, we predict that DLPFC stimulation should improve how patients respond to psychological therapy. This study has considerable implications as it will potentially benefit a large number of patients for which current treatments are ineffective.
详细描述
We propose to investigate the effect of applying transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (LDLPFC) immediately prior to each of 8 sessions of cognitive behavioural therapy (CBT), a type of psychological therapy. In addition we will investigate whether tDCS effects on CBT are due to changes in cognitive control using both behavioural and neuroimaging measures.
We hypothesize that tDCS, thanks to its enduring effects, should improve the benefits of CBT, through the enhancement of cognitive control in the patient.
Null hypothesis: mood and cognitive performance will be equivalent in depressed individuals who undergo tDCS and those who undergo sham stimulation.
Experimental hypothesis: mood and cognitive performance will be improved in depressed individuals who undergo tDCS relative to those who undergo sham stimulation.
Sixty patients suffering from depression will be recruited, and a double-blind, sham-controlled, randomised design will be used. This design means that neither participants nor researchers are aware of the conditions they have been assigned to, and has been chosen to eliminate participant expectancy ("placebo") effects and researcher bias. To ensure that 30 participants are included in each group, we will use a balanced assignment algorithm at entry into the study, which will maximise statistical power. Since the results of a study of this type have never previously been reported (to our knowledge), clinical equipoise exists, mandating the use of a sham stimulation arm. Patients with depression will be randomly assigned to one of two groups: tDCS or sham stimulation. To ensure that 30 participants are included in each group, we will use a balanced assignment algorithm at entry into the study. The whole study will be spread over 16 weeks for each participant with the following time course:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from unipolar major depressive disorder
- •First depressive episode onset before 40 years old
- •Right-handedness
- •English as first language
- •Intention to commence a course of cognitive behavioural therapy
排除标准
- •Antidepressant or other psychotropic medication at any time during the study or within previous 4 weeks (8 for fluoxetine)
- •Recent illicit drug use
- •Prior mixed, manic, or psychotic symptoms or other psychiatric or neurological illness
- •Standard exclusion criteria for MRI scanning: pregnancy, breast feeding, any immovable metal in the body, weight above 250 lbs, claustrophobia
- •tDCS safety criteria: skin disease or skin treatment that could potentially cause irritation with electrical stimulation
研究组 & 干预措施
Patients tDCS
A group of 30 patients will receive active tDCS stimulation once a week for 8 weeks, immediately prior to CBT.
干预措施: Transcranial direct current stimulation (tDCS) (Device)
Patients tDCS
A group of 30 patients will receive active tDCS stimulation once a week for 8 weeks, immediately prior to CBT.
干预措施: Cognitive Behavioural Therapy (Behavioral)
Patients - Sham
Another group of 30 patients will receive sham stimulation once a week during 8 weeks, immediately prior to CBT.
干预措施: Cognitive Behavioural Therapy (Behavioral)
结局指标
主要结局
Beck Depression Inventory (BDI) score
时间窗: Change from Baseline BDI score at 16 sessions or when the patient ceases CBT, whichever came first
BDI scores will constitute a self-report measure of depression.
Hamilton Depression Rating Scale (HAMD)
时间窗: Change from Baseline HAMD at 8 CBT sessions
HAMD scores will constitute an interview scale from baseline to end of tDCS.
Beck Depression Inventory (BDI) score
时间窗: Change from Baseline BDI score at 8 sessions
BDI scores will constitute a self-report measure of depression symptoms over the course of the trial.
次要结局
- Cognitive Control Performance(Week 0 (Baseline), 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Functional Magnetic Resonance Imaging (fMRI) data(Change from Baseline brain responses to the cognitive control task at week 9)