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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883257
• Other study ID #: 003/2016
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: April 19, 2018
• Start date: August 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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).

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Dalhousie University, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale	Depression symptom severity	16 weeks
Secondary	Quick Inventory of Depressive Symptomatology (QIDS)	Depression symptom severity	16 weeks
Secondary	World Health Organization Quality of Life Short Version (WHOQOL-BREF)	Quality of life	16 weeks
Secondary	Hamilton Depression Rating Scale (Ham-D)	Depression symptom severity	16 weeks
Secondary	Beck Depression Inventory (BDI)	Depression symptom severity	16 weeks
Secondary	Work and Social Adjustment Scale (WSAS)	Functioning and impairment	16 weeks

External Links

•   Information about research at the Centre for Addiction and Mental Health
•   Information about research by the Canadian Biomarker Integration Network in Depression