Status:
SUSPENDED
Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether onl...
Detailed Description
Depression is a commonly diagnosed mental health disorder that represents the most prevalent cause of disability worldwide. Cognitive Behavioural Therapy (CBT) is the best-evidenced treatment for depr...
Eligibility Criteria
Inclusion
- Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit;
- Psychiatrist diagnosis of Major Depression Disorder;
- Mini-International Neuropsychiatric Interview (MINI)-confirmed diagnosis of Major Depression Disorder;
- fluent in English.
Exclusion
- individuals currently receiving weekly structured psychotherapy;
- individuals who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or any other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder;
- individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months);
- individuals who are judged to have treatment resistant depression (TRD), as defined by failure in at least two trials of antidepressant medications and/or a course of psychotherapy during the current depressive episode
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04825535
Start Date
April 1 2024
End Date
April 1 2025
Last Update
April 8 2024
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4