RCT of MBCT vs HEP for Late-Life Depression

NCT05366088 | Terminated

• 1 other identifier: 427282
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression in Old Age; Quality of Life

Keywords

Late-life depression; Quality of Life; Mindfulness-Based Cognitive Therapy; Behavioural Activation; Executive Functioning; Processing Speed

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS) score

  Depression Symptoms, score results suggest mild, moderate or sever depression

  8 weeks

Secondary Outcomes (1)

• Quality of Life 5 dimensions

  8 weeks

Other Outcomes (2)

• executive functioning and processing speed

  8 weeks

• anxiety, Mindfulness Presence and global cognition

  8 weeks

Study Arms (2)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

Online group sessions 90minutes/week, for 8 weeks, and amount of home practice (\~30 mins/day, 6 days/week), 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).

Behavioral: Mindfulness-Based Cognitive Therapy

Health Enhancement Program

ACTIVE COMPARATOR

Online group sessions 90minutes/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.

Behavioral: Health Enhancement Program

Interventions

Mindfulness-Based Cognitive Therapy BEHAVIORAL

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.

Mindfulness-Based Cognitive Therapy

Health Enhancement Program BEHAVIORAL

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.

Health Enhancement Program

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Lady Davis Institute

Montreal, Quebec, H3T 1E1, Canada

Location

Related Publications (1)

• Bein M, Lesage M, Dikaios E, Chakravarty M, Segal Z, Royal I, Speechley M, Schiavetto A, Blumberger D, Sacchet MD, Therriault J, Gruber J, Tourjman V, Richard-Devantoy S, Nair V, Bruneau MA, Rej S, Lifshitz M, Sekhon H. 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. Front Aging Neurosci. 2022 Sep 1;14:976636. doi: 10.3389/fnagi.2022.976636. eCollection 2022.

  PMID: 36118690 DERIVED

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 9, 2022
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: May 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05

Locations

CA (1)