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

April 19, 2018 updated by: Lena Quilty, Centre for Addiction and Mental Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Therapy
  • 20 individual 60-minute appointments over the course of 16 weeks
  • Consistent with Beck, Rush, Shaw, and Emery (1979)
Behavioral: Cognitive 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

University Health Network, Toronto
Dalhousie University

Investigators

  • Principal Investigator: Lena C Quilty, PhD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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