Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression

Study Overview
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Brief Summary
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The purpose of this study is to locate clinical markers (for example, interviews, questionnaires, and computer tasks) and biological markers (for example, physiological, blood-based, or electroencephalography measurements) that predict response to cognitive behavioral therapy for depression.

Detailed Description
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Forty adult outpatients with major depressive disorder or persistent depressive disorder will receive up to 20 sessions of cognitive behavioral therapy for depression over 16 weeks. Participants will complete clinical measures (interviews, questionnaires, and computer-based tasks) and biological measures (blood tests, physiological measurements, electroencephalography ) before, during, and after treatment.

Official Title
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Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Major Depressive Disorder or Persistent Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Must be fluent in English Must be capable to give informed consent Exclusion Criteria: Lifetime diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder Current Alcohol or Drug Use Disorder (except tobacco or caffeine) Current psychotic symptoms Acute suicide risk Psychological treatment for depression initiated during the past three months Pharmacological treatment for depression initiated/changed during the past three months Previous non-response to two or more adequate trials of pharmacotherapy Current significant neurological disorder, head trauma, or unstable medical conditions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>20 individual 60-minute appointments over the course of 16 weeks Consistent with Beck, Rush, Shaw, and Emery (1979) | Behavioral: Cognitive Behavioral Therapy<br>* Cognitive Behavioral Therapy will include core mandatory modules of key effective components (e.g., behavioural activation, cognitive restructuring) and optional elements to address individual maintaining factors (e.g., coping and social skills training, perfectionism and self-criticism).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale | Depression symptom severity | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptomatology (QIDS) | Depression symptom severity | 16 weeks | 
| World Health Organization Quality of Life Short Version (WHOQOL-BREF) | Quality of life | 16 weeks | 
| Hamilton Depression Rating Scale (Ham-D) | Depression symptom severity | 16 weeks | 
| Beck Depression Inventory (BDI) | Depression symptom severity | 16 weeks | 
| Work and Social Adjustment Scale (WSAS) | Functioning and impairment | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depression, Major Depressive Disorder, Persistent Depressive Disorder, Cognitive Behavioral Therapy, Biomarkers