Neuroimaging Markers of Midlife Depression and Cognitive Behavioural Therapy (CBT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

12 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.

Interventions

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Cognitive Behavioural Therapy

12 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 40-60 years, inclusive.
2. Diagnosis of MDD as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)6 determined through a structured clinical interview.
3. Current major depressive episode of at least 3 months in length.
4. Depression of at least mild severity defined by a total score of ≥7 on the Montgomery Asberg Depression Rating Scale (MADRS)7.
5. Ability to understand and comply with the requirements of the study, as judged by the investigator(s).

Exclusion Criteria

1. Presence of comorbid post-traumatic stress disorder, obsessive-compulsive disorder, eating disorder(s), schizophrenia, or other psychiatric disorders.
2. History of a manic, hypomanic, or mixed depressive episode.
3. Treatment with electroconvulsive therapy, intravenous and/or intranasal ketamine in the 6-weeks prior to study enrolment.
4. History of substance-use disorder in the past 12 months.
5. Presence of current alcohol-use disorder
6. A positive urine toxicology screen for non-prescribed substance use.
7. A positive pregnancy test at screening.
8. A history of major medical or neurological illness.
9. A history of traumatic brain injury, stroke, seizures, or previous brain surgery.
10. Contraindications to magnetic resonance imaging (MRI) scanning.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No