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 range
60 Years – 100 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. substance abuse within the past 6 months
. high suicide risk (e.g., active suicidal ideation and/or recent intent or plan)
. significant visual or hearing impairment
. significant impairments in fine motor skills
. any medical illnesses that could prevent the participant from engaging in the intervention
. history of psychiatric hospitalization in the last 3 months