MBCT vs HEP in Patients With Late-Life Depression

Not Applicable

Not yet recruiting

• Conditions: Cognitive Decline; Depression in Old Age
• Interventions: Behavioral: Health Enhancement Program; Behavioral: Mindfulness-Based Cognitive Therapy

• Registration Number: NCT05366088
• Lead Sponsor: Lady Davis Institute

Brief Summary

Study Design \& Recruitment: Phase III randomized controlled trial (RCT) with 200 patients. Participants with a diagnosis of late-life depression (LLD), excluding dementia and other psychiatric comorbidities, will be recruited at three health networks. LLD patients had no earlier depressive episodes before the age of 65.

Interventions: Mindfulness-based Cognitive Therapy (MBCT) or Health Enhancement Program (HEP) for 8-weeks, in addition to 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.

Detailed Description

Late life depression (LLD) affects 5 million American seniors yearly with $1.81 billion in direct health-care costs. Biomarkers of LLD have consistently been linked to elevated dementia risk. Mindfulness-based cognitive therapy (MBCT) holds promise for treating symptoms of depression, ameliorating cognitive deficits and preventing decline in older adults by targeting brain circuits implicated in memory and attention. While preliminary findings are promising, the effects of mindfulness on cognition and brain markers have not been assessed in older adults with depression who are especially vulnerable to cognitive decline. This proposed research will explore 1) whether MBCT's mechanism of action in treating symptoms of depression and preventing cognitive decline is behavioural activation or mindfulness, two components of MBCT, 2) the role of environmental factors, 3) whether benefits persist in the medium term, and 4) the persistence of key cognitive and brain markers associated with the treatment of LLD.

Two-hundred and thirteen (n = 213) patients with LLD will be recruited at various centres in Montreal (affiliated with McGill University, Université de Montréal and University of Toronto). Participants will undergo stratified randomization to either MBCT or Health Enhancement Program (HEP) intervention groups. The investigators will assess changes in (1) depression severity, (2) processing speed and executive functioning, (3) hippocampal volume, resting-state functional connectivity and vascular risk factors, and (4) other exploratory physiological and mood-based measures, at baseline (0 weeks), post intervention (8 weeks), and 26 weeks after baseline. Raters and clinicians will be blinded to group allocation while participants will be blinded to the study hypotheses.

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. If MBCT is found to be effective in treating LLD and preventing cognitive decline, the potential exists to implement this intervention at the study sites, across Canada, and internationally.

Study Timeline

• Study First Submitted: 2022-04-26
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-04
• Last Update Submitted: 2022-05-04
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Study Start: 2022-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• Major depressive disorder as assessed by the Mini International Neuropsychiatric Inventory (MINI). Following the MINI assessment, a psychiatrist will verify the diagnosis of major depressive disorder.
• Hamilton Depression scale (HAM-D17) score ≥ 10
• Participants willing and able to attend ≥75% of MBCT/HEP sessions
• Sufficient hearing to follow verbal instructions
• Adequate understanding of English and/or French
• Ability to sit for 40 minutes without discomfort.

Exclusion Criteria

• Inability to provide informed consent
• Evidence of dementia as defined by MoCA scores
• Lifetime diagnosis of 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
• Substance abuse/dependence within the past 6 months
• High suicide risk (e.g., active suicidal ideation and/or current/recent intent or plan)
• Non-correctable, clinically significant sensory impairment
• Significant impairments in fine motor skills
• Acutely unstable medical illnesses, including delirium, acute cerebrovascular/cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months;
• Currently practicing any mind-body intervention on a regular basis
• Unwilling or unable to remain on the same psychotropic medications (includes dosage) for the first 8 weeks of the study
• Any of the following contraindications for a magnetic resonance study: pacemaker, aneurysm clip, heart/vascular clip, prosthetic valve, metal prosthesis, claustrophobia, metal fragments in body, and transdermal patches.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Enhancement Program	Health Enhancement Program	Group sessions 2 hrs/week for 8 weeks, and amount of home practice (\~30 mins/day, 6 days/week). HEP will be delivered by social workers (or equivalent) who have received the official training course from HEP's developers at the University of Wisconsin.
Mindfulness-Based Cognitive Therapy	Mindfulness-Based Cognitive Therapy	Group sessions 2 hours/week, for 8 weeks, based on the manualized protocol developed by co-I Dr. Segal and will be delivered by social workers (or equivalent) with ≥3 years of experience delivering MBCT and training for official certification from the Center for Mindfulness Studies (Toronto).

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAM-D17) score	26 weeks	Depression Symptoms, rated from 0 tp 54. Higher scores mean more depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Hippocampal volume	26 weeks	T1 weighted MPRAGE will be acquired (TE/TR=2.98 ms/2300 ms, TI=900 ms, α=9°, FOV= 256 x 240 x 192 mm, GRAPPA of 2, 5 min). Volumetry of the hippocampus and its subfields will be identified using the MAGeT Brain algorithm.
WAIS-IV Digit Symbol score	26 weeks	Processing Speed. Scores range from 0 to 100 with higher scores indicating higher processing speed.
WAIS- IV Digit Span score	26 weeks	Executive Functioning. Scores range from 0 to 16 with higher scores indicating better executive functioning.
Resting-state functional connectivity	26 weeks	Resting-state functional MRI data will be acquired using simultaneous multislice echo planar imaging sequence (62) with a scan time of \~5 mins, with the following parameters: TE/TR=30 ms/1000 ms, 300 frames, slice thickness= 2.5 mm, and 2.5 mm isotropic in-plane resolution, and slice acceleration factor (SMS) of 4. A matching B0 field map will be acquired with an approximate scan time of 1.5 min, with the following parameters: TE 1=4.92 ms, TE 2=7.38 ms, TR=688 ms.