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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major Depression, Major Depressive Disorder, Persistent Depressive Disorder, Cognitive Behavioral Therapy, Biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Behavioral Therapy

Arm Description

20 individual 60-minute appointments over the course of 16 weeks Consistent with Beck, Rush, Shaw, and Emery (1979)

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale
Depression symptom severity

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2016
Last Updated
April 19, 2018
Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto, Dalhousie University
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1. Study Identification

Unique Protocol Identification Number
NCT02883257
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
University Health Network, Toronto, Dalhousie University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Major Depression, Major Depressive Disorder, Persistent Depressive Disorder, Cognitive Behavioral Therapy, Biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
20 individual 60-minute appointments over the course of 16 weeks Consistent with Beck, Rush, Shaw, and Emery (1979)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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 Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale
Description
Depression symptom severity
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology (QIDS)
Description
Depression symptom severity
Time Frame
16 weeks
Title
World Health Organization Quality of Life Short Version (WHOQOL-BREF)
Description
Quality of life
Time Frame
16 weeks
Title
Hamilton Depression Rating Scale (Ham-D)
Description
Depression symptom severity
Time Frame
16 weeks
Title
Beck Depression Inventory (BDI)
Description
Depression symptom severity
Time Frame
16 weeks
Title
Work and Social Adjustment Scale (WSAS)
Description
Functioning and impairment
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena C Quilty, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34419752
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.
Results Reference
derived
Links:
URL
http://www.camh.ca/research
Description
Information about research at the Centre for Addiction and Mental Health
URL
http://www.canbind.ca
Description
Information about research by the Canadian Biomarker Integration Network in Depression

Learn more about this trial

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

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