Neuroimaging Markers of Midlife Depression and Cognitive Behavioural Therapy (CBT)
ConditionMajor Depressive Disorder (MDD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorBaycrest
About this trial
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:
1. Investigate the clinical impact of CBT on cognitive function and mood outcomes in midlife depression 2. Examine functional connectivity and microstructural determinants of CBT response in midlife depression using neuroimaging 3. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)7.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive Behavioural Therapy
Behavioral12 weeks of Cognitive Behavioural Therapy (CBT) will be administered. The first session will be accomplished in-person at Baycrest Hospital. After that, therapy will be conducted virtually, via video-conference. Individuals will undergo therapy once a week for approximately 1 hour, for 12-weeks. Following the 12-week period, individuals will receive three follow-up assessments with their therapist at 3, 6, and 9 months.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MADRS
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.
Time frame
Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).2
DARS
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.
Time frame
Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).Secondary outcomes
1
T1-anatomical
A T1 anatomical MRI, also known as a T1-weighted MRI, is a type of magnetic resonance imaging (MRI) sequence that excels at visualizing the structural details of tissues, particularly soft tissues and fat. It's often used to provide a clear view of the b
Time frame
Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).2
Diffusion-tensor MRI
Diffusion tensor MRI (DTI) is an advanced magnetic resonance imaging (MRI) technique that maps the diffusion of water molecules in the brain to visualize the white matter pathways. It provides insights into the structural organization and integrity of white matter, which is crucial for understanding brain connectivity and function.
Time frame
Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks).3
Resting-state fMRI
Resting state fMRI (rs-fMRI) is a technique used to study brain activity when a person is not performing a specific task. It focuses on spontaneous fluctuations in the blood-oxygen-level-dependent (BOLD) signal to identify functional connections between different brain regions. We will use this signal to compute functional connectivity
Time frame
Once before administration of Cognitive Behavioural Therapy (CBT) and once after (baseline and 12 weeks). Source ClinicalTrials.gov
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