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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02883257
Enrollment
41
Registered
2016-08-30
Start date
2016-08-31
Completion date
2017-11-30
Last updated
2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Major Depression, Major Depressive Disorder, Persistent Depressive Disorder, Cognitive Behavioral Therapy, Biomarkers

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

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).

Sponsors

University Health Network, Toronto
CollaboratorOTHER
Dalhousie University
CollaboratorOTHER
Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Montgomery Asberg Depression Rating Scale16 weeksDepression symptom severity

Secondary

MeasureTime frameDescription
Quick Inventory of Depressive Symptomatology (QIDS)16 weeksDepression symptom severity
World Health Organization Quality of Life Short Version (WHOQOL-BREF)16 weeksQuality of life
Hamilton Depression Rating Scale (Ham-D)16 weeksDepression symptom severity
Beck Depression Inventory (BDI)16 weeksDepression symptom severity
Work and Social Adjustment Scale (WSAS)16 weeksFunctioning and impairment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026