Neuroimaging Markers of Midlife Depression and Cognitive Behavioural Therapy (CBT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MADRS
研究概览
简要总结
Major depressive disorder (MDD) is associated with significant cognitive impairment throughout the life-course, which may progress toward MCI and dementia with age. Antidepressant medications are the first line of treatment; however, they fail to adequately address cognitive deficits and prevent relapse. Sustained cognitive impairment into euthymic periods may relate to underlying neurobiological changes, which could potentially be addressed through Cognitive Behavioural Therapy (CBT). Notably, CBT has been shown to improve cognitive domains including divided attention, memory, and processing speed while preventing depression relapse. Midlife represents a critical period in which shared neurobiological factors (such as brain changes on a vascular, morphological, and functional level) underlying depression and cognitive impairment could accelerate toward MCI and dementia. An updated understanding of neurobiological correlates of midlife depression and CBT response through multimodal neuroimaging is critical to improving affective and cognitive outcomes in this population.
The overarching objective of this project is to use multimodal neuroimaging to quantify the neurobiological and clinical impact of CBT in midlife depression. Specifically, we aim to:
- Investigate the clinical impact of CBT on cognitive function and mood outcomes in midlife depression
- Examine functional connectivity and microstructural determinants of CBT response in midlife depression using neuroimaging
- Identify vascular modulators of neural connectivity and CBT response in midlife depression.
We hypothesize that midlife depression will be associated with functional and structural neural connectivity changes, which will be accompanied by vascular pathology. Adequate CBT response (i.e., improvements in mood and cognitive function) will be associated with amelioration of neurobiological changes.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-60 years, inclusive.
- •Diagnosis of MDD as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)6 determined through a structured clinical interview.
- •Current major depressive episode of at least 3 months in length.
- •Depression of at least mild severity defined by a total score of ≥7 on the Montgomery Asberg Depression Rating Scale (MADRS)
- •Ability to understand and comply with the requirements of the study, as judged by the investigator(s).
排除标准
- •Presence of comorbid post-traumatic stress disorder, obsessive-compulsive disorder, eating disorder(s), schizophrenia, or other psychiatric disorders.
- •History of a manic, hypomanic, or mixed depressive episode.
- •Treatment with electroconvulsive therapy, intravenous and/or intranasal ketamine in the 6-weeks prior to study enrolment.
- •History of substance-use disorder in the past 12 months.
- •Presence of current alcohol-use disorder
- •A positive urine toxicology screen for non-prescribed substance use.
- •A positive pregnancy test at screening.
- •A history of major medical or neurological illness.
- •A history of traumatic brain injury, stroke, seizures, or previous brain surgery.
- •Contraindications to magnetic resonance imaging (MRI) scanning.
研究组 & 干预措施
Experimental Group
Individuals with midlife depression (MDD, ages 40-60 years) will undergo 12 weeks of CBT, in addition to three follow-up assessments, clinical evaluation (including completion of self-report and clinician-rated questionnaires) and pre-post CBT magnetic resonance imaging (MRI).
干预措施: Cognitive Behavioural Therapy (Behavioral)
结局指标
主要结局
MADRS
时间窗: Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale used to assess the severity of depressive symptoms. It is a 10-item scale, with each item rated on a 7-point scale, and the total score ranges from 0 to 60, with higher scores indicating more severe depression. The MADRS is commonly used in clinical trials and research to evaluate treatment response in individuals with depression.
DARS
时间窗: Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).
The Dimensional Anhedonia Rating Scale (DARS) is a 17-item self-report scale used to assess anhedonia, a core symptom of depression characterized by a reduced ability to experience pleasure. It measures anhedonia across four domains: hobbies, food/drink, social activities, and sensory experiences, evaluating aspects like desire, motivation, effort, and consummatory pleasure.
次要结局
- Diffusion-tensor MRI(Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).)
- Resting-state fMRI(Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).)
- T1-anatomical(Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).)
研究者
Jean Chen
Senior Scientist
Baycrest