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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT02883257
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	* 20 individual 60-minute appointments over the course of 16 weeks * Consistent with Beck, Rush, Shaw, and Emery (1979)

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale	16 weeks	Depression symptom severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada