Clinical trial NCT02883257: Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression
Official title: Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Major Depression
Major Depressive Disorder
Persistent Depressive Disorder
Cognitive Behavioral Therapy
Biomarkers
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Dalhousie University
First posted: 2016-08-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: 16 weeks
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: 16 weeks
measure: World Health Organization Quality of Life Short Version (WHOQOL-BREF)
timeFrame: 16 weeks
measure: Hamilton Depression Rating Scale (Ham-D)
timeFrame: 16 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 16 weeks
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Lena C Quilty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones BDM, Levitan RD, Wang W, Uher R, Rotzinger S, Foster JA, Kennedy SH, Farzan F, Quilty LC, Kloiber S. Metabolic variables associated with response to cognitive behavioural therapy for depression in females: A Canadian biomarker integration network for depression (CAN-BIND) study. J Psychiatr Res. 2021 Oct;142:321-327. doi: 10.1016/j.jpsychires.2021.07.031. Epub 2021 Jul 21.