MedTrace Logo

RCT of MBCT vs HEP for Late-Life Depression

NCT05366088 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-10

No results posted yet for this study

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

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Lady Davis Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-10-01
Completion
2025-05-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05366088 on ClinicalTrials.gov