WithdrawnNot Applicable

Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi

Stopped: Study closed prematurely

Canada0Started 2020-12-15

Plain-language 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 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)

Timeframe: Baseline and 4 months

Trial details

NCT IDNCT04825535

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-25