NCT02883257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

August 19, 2016

Last Update Submit

April 19, 2018

Conditions

Depression

Keywords

Major DepressionMajor Depressive DisorderPersistent Depressive DisorderCognitive Behavioral TherapyBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale

    Depression symptom severity

    16 weeks

Secondary Outcomes (5)

  • Quick Inventory of Depressive Symptomatology (QIDS)

    16 weeks

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

    16 weeks

  • Hamilton Depression Rating Scale (Ham-D)

    16 weeks

  • Beck Depression Inventory (BDI)

    16 weeks

  • Work and Social Adjustment Scale (WSAS)

    16 weeks

Study Arms (1)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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).

Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34419752DERIVED

Related Links

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lena C Quilty, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Independent Scientist

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 30, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)