MBCT vs HEP in Patients With Late-Life Depression

Cognitive Decline Clinical Trial

Official title:

Mindfulness-Based Cognitive Therapy (MBCT) vs. Health Enhancement Program (HEP) Active Control for the Treatment of Late-Life Depression: An RCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05366088
• Other study ID #: 427282
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2022
• Source: Lady Davis Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 213
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Depression
• Depression in Old Age
• Depressive Disorder

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy
MBCT is an 8-week therapy integrating formal mindfulness meditation (e.g. breath and body awareness) and informal mindfulness (e.g. eating, walking). Participants are taught to attend non-judgmentally to present moment experiences. MBCT includes cognitive therapy techniques to target the ruminative thought processes and identification with negative emotions seen in depression. MBCT teaches participants how to disengage from habitual ("automatic") dysfunctional cognitive routines, in particular depression-related ruminative thought patterns that perpetuate depressive symptoms and increase vulnerability to relapse.
• Health Enhancement Program
HEP teaches health-enhancing techniques and was designed by University of Wisconsin and NIH as a manualized active control group program for mindfulness-based intervention trials (53,54). We have tailored HEP to be structurally equivalent to MBCT. 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. Participants will learn about health promotion, healthy diet, music, and gentle exercise, but not about breathing techniques or meditation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lady Davis Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vascular risk factors	Fluid Attenuated Inversion Recovery (FLAIR) imaging sequence to detect small vessel disease burden and a Quantitative Susceptibility Mapping (QSM) assessment based on T2*-weighted imaging to assess microbleeds and iron accumulation which may lead to neurodegeneration.	26 weeks
Primary	Hamilton Depression Rating Scale (HAM-D17) score	Depression Symptoms, rated from 0 tp 54. Higher scores mean more depressive symptoms.	26 weeks
Secondary	Hippocampal volume	T1 weighted MPRAGE will be acquired (TE/TR=2.98 ms/2300 ms, TI=900 ms, a=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.	26 weeks
Secondary	Resting-state functional connectivity	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.	26 weeks
Secondary	WAIS-IV Digit Symbol score	Processing Speed. Scores range from 0 to 100 with higher scores indicating higher processing speed.	26 weeks
Secondary	WAIS- IV Digit Span score	Executive Functioning. Scores range from 0 to 16 with higher scores indicating better executive functioning.	26 weeks