RCT of MBCT vs HEP for Late-Life Depression (NCT05366088) | Clinical Trial Compass
TerminatedNot Applicable
RCT of MBCT vs HEP for Late-Life Depression
Stopped: Double record
Canada100 participantsStarted 2023-10-01
Plain-language summary
Study Design \& Recruitment: Phase III randomized controlled trial (RCT) with 100-110 patients. Participants \>60 years old, with symptoms of late-life depression (LLD; MADRS score\>=10), excluding dementia and other psychiatric comorbidities, will be recruited in Montreal and via social media, across Canada.
Interventions: Mindfulness-based Cognitive Therapy (MBCT) or Health Enhancement Program (HEP) for 8-weeks, in addition to treat as usual (TAU). MBCT and HEP will have the same group sizes, meeting frequency, and amount of home practice. HEP is a recognized active control where participants learn about diet and exercise, but not meditation.
Who can participate
Age range60 Years – 100 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
✓. MADRS score ≥ 10 (experiencing symptoms of moderate/severe depression) at baseline
✓. Ability to provide informed consent (shown as to be able to explain back to the research assistant the purpose of the study as well as voluntary participation, rights, time commitments, etc.)
✓. participants who have access to internet and basic digital skills to use their computer/tablet
✓. willing and able to attend ≥75% of MBCT or HEP sessions
✓. adequate understanding of English or French
✓. ability to sit for 90 minutes without discomfort
✓. willing to inform if any change is made to their psychotropic medications and dosage for the first 8 weeks of the study
Exclusion criteria
✕. cognitive deficits at baseline, as defined by MoCA score \<19
✕. diagnosis of post-traumatic stress disorder, bipolar I or II disorder, primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder), and/or severe personality disorder interfering with ability to function in a group setting intervention on a regular basis