Alternative Treatments To Prevent Cognitive Decline in Older Adults With Depression and Anxiety

NCT03607708 | Suspended

• 1 other identifier: LadyDI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Major depression and anxiety disorders are leading causes of disability worldwide. These mental disorders deeply impact social functioning and physical health in more than 300,000-600,000 Canadians over the age of 60. Depressed and anxious older adults have a 2-3 times increased risk of developing dementia and cognitive decline. Mindfulness-based cognitive therapy (MBCT) is a group meditation intervention that has been beneficial in treating depression and anxiety in younger adults. Our research group has experience conducting clinical trials of MBCT in older adults with depression and anxiety. Meditation therapies may prevent cognitive decline, but no previous study has examined this with MBCT. In this 8-week clinical trial, Investigators are examining whether MBCT can strengthen the structural and functional integrity of brain networks and improve cognitive resilience in vulnerable depressed and anxious older adults. Investigators will also examine whether MBCT can improve depression, anxiety symptoms, disability, and quality of life in patients. Investigators will conduct a pilot randomized controlled trial (RCT), comparing Mindfulness-Based Cognitive Therapy (MBCT; n=15) versus a Health Enhancement Program (HEP; n=15) active control in 30 older patients (\>60) with depression or anxiety. Participants will be blinded to the treatment hypothesis while investigators and raters will be additionally blinded to group assignment. Both MBCT and HEP will be taught in weekly sessions over 8 weeks in similar sized groups (4-10 participants). Investigators will measure the effect of these interventions on brain network function and structure using magnetic resonance imaging at baseline and 8-week timepoints. Investigators will also assess cognitive functioning and a range of clinical symptoms/quality of life measures at baseline, 8-week and 6-month follow-up. Investigators anticipate that this project will improve quality of life in depressed and anxious older adults by enhancing brain resilience, cognitive function, and general mental health. This project will provides essential pilot data for a longer-term definitive neuroimaging trial of MBCT to assess the potential of this intervention to prevent cognitive decline and dementia in older adults.

Conditions

Depression Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• Changes in functional connectivity (rs-fMRI) from baseline to 8- week follow -up

  Using an 8- week RCT, assess the effects of MBCT (compared to an active control condition) on functional integrity of key default- mode network (DMN) nodes using functional connectivity measured by resting-state fMRI, Hypothesis . Compared to HEP controls, MBCT- treated patients will show larger increases from baseline to 8- week follow -up in 1) functional connectivity between regions implicated in the DMN

  Baseline and 8 weeks

• Structural Volume Change using structural sMRI from baseline to 8- week follow -up

  Using an 8- week RCT, assess the effects of MBCT (compared to an active control condition) on changes in changes Structural Volume Investigators hypothesis : Compared to HEP controls, MBCT- treated patients will show volume increase from baseline to 8- week follow -up in the bilateral hippocampal and posterior cingulate cortex nodes of the DMN,

  Baseline and 8 weeks

• Changes in Glutathione measured by magnetic resonance spectroscopy(MRS) from baseline to 8- week follow -up

  Increase in levels of Glutathione from baseline to 8- week follow -up in key mood regulating brain areas of the DMN (ventro-medial prefrontal cortex).

  Baseline and 8 weeks

Secondary Outcomes (1)

• Improvements in cognitive functio

  Baseline and 8 weeks

Other Outcomes (8)

• Improvements in patient depression (PHQ-9)

  Baseline, 8 weeks and 26 -week follow-up

• Improvement in Cognition 26- week follow-up.

  26 -week follow-up

• changes in Blood inflammation markers from baseline to 8 weeks

  Baseline and 8 weeks

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

The MBCT intervention will consist of group conducted meditative practices, lasting 2 hours per week for 8 weeks. Patients will be invited to try various techniques during sessions (brief silent meditations, guided meditations, body scans, gentle arm movement exercises).

Other: Mindfulness-Based Cognitive Therapy (MBCT)

Health Enhancement Program (HEP)

ACTIVE COMPARATOR

Health Enhancement Program (HEP) : Has been previously designed and used for the purpose of being a manualized active control in meditation-based intervention trials, controlling for several non-specific factors found in a mindfulness meditation group. Participants will learn about health promotion, healthy diet, music, exercise as well as implementing positive health-enhancing life changes both in-session and during at-home practice with the support of a group facilitator, but do not learn mindfulness techniques.

Other: Health Enhancement Program (HEP)

Interventions

Mindfulness-Based Cognitive Therapy (MBCT) OTHER

The MBCT intervention will consist of group conducted meditative practices, lasting 2 hours per week for 8 weeks. Patients will be invited to try various techniques during sessions (brief silent meditations, guided meditations, body scans, gentle arm movement exercises).

Mindfulness-Based Cognitive Therapy (MBCT)

Health Enhancement Program (HEP) OTHER

Health Enhancement Program (HEP) : Has been previously designed and used for the purpose of being a manualized active control in meditation-based intervention trials, controlling for several non-specific factors found in a mindfulness meditation group. Participants will learn about health promotion, healthy diet, music, exercise as well as implementing positive health-enhancing life changes both in-session and during at-home practice with the support of a group facilitator, but do not learn mindfulness techniques.

Health Enhancement Program (HEP)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be \>60 years of age presenting with clinically meaningful symptoms of depression or anxiety (PHQ-9 or GAD-7 scores ≥10).
• Participants will be willing and able to attend at least 75% of weekly HEP or MBCT sessions.
• Have sufficient hearing to follow verbal instructions;
• Have adequate understanding of English and/or French.
• Able to sit for 20-25 minutes without discomfort.

You may not qualify if:

• Inability to provide informed consent.
• Clinical evidence of dementia as defined by the Mini-Cog; a lifetime diagnosis of bipolar I or II disorder or primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
• High acute risk of suicide (e.g., active suicidal ideation and/or current/recent intent or plan).
• Severe personality disorder, that will interfere with their ability to function in a group setting.
• Active substance use; non-correctable.
• Clinically significant sensory impairment.
• Diagnosed Intellectual Deficiency (e.g. Childhood Mental Retardation, Autism)
• Acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months.
• Currently practicing any form of meditation on a regular basis.
• Unwilling to remain on the same psychotropic medications including dosage for the first 8 weeks of the study

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (2)

Lady David Institute

Montreal, Quebec, H3T 1E2, Canada

Location

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Related Publications (1)

• Thomas Z, Novak M, Platas SGT, Gautier M, Holgin AP, Fox R, Segal M, Looper KJ, Lipman M, Selchen S, Mucsi I, Herrmann N, Rej S. Brief Mindfulness Meditation for Depression and Anxiety Symptoms in Patients Undergoing Hemodialysis: A Pilot Feasibility Study. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2008-2015. doi: 10.2215/CJN.03900417. Epub 2017 Oct 12.

  PMID: 29025788 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Soham Rej, MD/MSc

  Lady David Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: RCT

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 31, 2018
• Study Start: June 10, 2019
• Primary Completion: December 20, 2021
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-04

Locations

CA (2)