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Completed

NCT Number: NCT02883257

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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).

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale

    Time frame: 16 weeks

    Depression symptom severity

Secondary outcomes

  1. Quick Inventory of Depressive Symptomatology (QIDS)

    Time frame: 16 weeks

    Depression symptom severity

  2. World Health Organization Quality of Life Short Version (WHOQOL-BREF)

    Time frame: 16 weeks

    Quality of life

  3. Hamilton Depression Rating Scale (Ham-D)

    Time frame: 16 weeks

    Depression symptom severity

  4. Beck Depression Inventory (BDI)

    Time frame: 16 weeks

    Depression symptom severity

  5. Work and Social Adjustment Scale (WSAS)

    Time frame: 16 weeks

    Functioning and impairment

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Dalhousie University
  • University Health Network, Toronto

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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