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

NCT ID: NCT02883257

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive Behavioral Therapy

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Dalhousie University

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lena Quilty

Independent Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lena C Quilty, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34419752 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.camh.ca/research

Information about research at the Centre for Addiction and Mental Health

http://www.canbind.ca

Information about research by the Canadian Biomarker Integration Network in Depression

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

003/2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rhythm and Depression
NCT02857036 UNKNOWN NA