Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi
Reason given: Study closed prematurely
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Trial details
- Who runs it
- Centre for Addiction and Mental Health
- Trial code
- NCT04825535
- Record updated
- 7 April 2026
- Original description
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 online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.Read full original descriptionShow less
A Non-Inferiority Randomized Controlled Trial Comparing Online and On-Site Cognitive Behaviour Therapy in Major Depressive Disorder
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 online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.
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 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; individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months).