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Mindfulness-based cognitive therapy vs. a health enhancement program for the treatment of late-life depression: Study protocol for a multi-site randomized controlled trial.

Magnus Bein, Myriam Lesage, Elena Dikaios, Mallar Chakravarty, Zindel V. Segal, Isabelle Royal, Mark Speechley, Alessandra Schiavetto, Daniel M. Blumberger, Matthew D. Sacchet, Joseph Therriault, Johanna Gruber, Valérie Tourjman, Stephane Richard-Devantoy, Vasavan P Nair, Marie Andree-Bruneau, Soham Rej, Michael Lifshitz, Harmehr Sekhon

Frontiers in Aging Neuroscience January 1, 2022 DOI: 10.3389/fnagi.2022.976636 (opens in new tab) via PubMed

Summary

AI-generated from the abstract

Late-life depression affects up to 18% of older adults and is linked to elevated dementia risk. Mindfulness-based cognitive therapy (MBCT) may help treat depressive symptoms and cognitive deficits in this population, but a definitive randomized controlled trial has not yet been conducted. This protocol describes a multi-site blinded trial comparing MBCT to an active control, a Health Enhancement Program, in 213 patients with late-life depression. Changes in depression severity, processing speed, executive functioning, and brain biomarkers will be assessed at baseline, post-intervention (8 weeks), and 26 weeks after baseline. The study will evaluate MBCT's potential to improve depression, cognitive impairments, and neurobiological markers.

Study at a glance

Characteristics Randomized controlled trial Peer reviewed
Sample size 213
Population Patients with late-life depression in Montreal, QC, Canada
Interventions Mindfulness-based cognitive therapy Health Enhancement Program
Duration 8-week intervention, 26-week follow-up
Topics Meditation
Keywords Behavioral activation Cognitive function Executive function Late-life depression Memory
Registration NCT05366088
Key finding This is a protocol; no results are reported yet.

Abstract

Late-life depression (LLD) affects up to 18% of older adults and has been linked to elevated dementia risk. Mindfulness-based cognitive therapy (MBCT) holds promise for treating symptoms of depression and ameliorating cognitive deficits in older adults. While preliminary findings are promising, a definitive RCT investigating its effects on late life depression and cognition have not yet been conducted. We present a protocol describing a multi-site blinded randomized controlled trial, comparing the effects of MBCT and of an active control, a Health Enhancement Program (HEP), on depressive symptoms, executive functioning, and brain biomarkers of LLD, among several other exploratory outcomes. Two-hundred and thirteen (n = 213) patients with LLD will be recruited at various centers in Montreal, QC, Canada. Participants will undergo stratified randomization to either MBCT or HEP intervention groups. We will assess changes in (1) depression severity using the Hamilton Depression Rating Scale (HAM-D17), (2) processing speed and executive functioning, (3) brain biomarkers of LLD (hippocampal volume, default network resting-state functional connectivity and executive network resting-state functional connectivity), and (4) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (8 weeks), and 26 weeks after baseline. The proposed study will assess the clinical potential of MBCT to improve symptoms of depression, as well as examine its impact on cognitive impairments and neurobiological markers, and thus inform its use as a promising adjunct in the treatment of LLD. www.ClinicalTrials.gov, identifier: NCT05366088.

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