RCT of MBCT vs HEP for Late-Life Depression

NCT ID: NCT05366088

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-05-01

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.

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 delivered through virtual videoconferencing platforms have not been assessed in older adults with depression. This proposed research aims are:

Primary Objective: Using an 8-week RCT, assess whether MBCT improves scores of LLD and quality of life compared to an active control (Health Enhancement Program (HEP)). Hypothesis 1(A): The MBCT group will have a lower score in the Montgomery Asberg Depression Scale (MADRS) at 8-weeks, compared to HEP controls. Hypothesis 1(B): The MBCT group will have higher scores of quality of life (EQ-5D) scores at 8-weeks.

Secondary Objective: To investigate the effects of MBCT on cognitive function in LLD. Hypothesis 2: MBCT will lead to higher scores in executive functioning and processing speed at 8 weeks.

Exploratory Objective: To investigate effects of MBCT on scores of anxiety (GAD-7) and mindfulness presence (Five-Factor Mindfulness Questionnaire (FFMQ) Hypothesis 3(A): The MBCT group will have reduced scores in the Generalized Anxiety Disorder 7 (GAD-7) at 8-weeks, compared to HEP controls. Hypothesis 3(B): The MBCT group will have a higher score in mindfulness presence (FFMQ), compared to HEP controls.

One-hundred (n =100) patients with LLD will be recruited at various centres in Montreal and throughout Canada via social media. Participants will undergo stratified randomization to either MBCT or Health Enhancement Program (HEP) intervention groups. The investigators will assess changes in (1) depression symptoms and quality of life, (2) processing speed and executive functioning, (3) anxiety and mindfulness presence, at baseline (0 weeks), post intervention (8 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 quality of life and cognition. If virtual delivery of MBCT is found to be effective in treating LLD and improving quality of life, the potential exists to implement this intervention at the study sites, across Canada, and internationally.

Conditions

Depression in Old Age; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness-Based Cognitive Therapy

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).

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Intervention Type: 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.

Health Enhancement Program

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.

Group Type: ACTIVE_COMPARATOR

Health Enhancement Program

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. MADRS score ≥ 10 (experiencing symptoms of moderate/severe depression) at baseline

2. 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.)

3. participants who have access to internet and basic digital skills to use their computer/tablet

4. willing and able to attend ≥75% of MBCT or HEP sessions

5. adequate understanding of English or French

6. ability to sit for 90 minutes without discomfort

7. willing to inform if any change is made to their psychotropic medications and dosage for the first 8 weeks of the study

Exclusion Criteria

1. cognitive deficits at baseline, as defined by MoCA score <19

2. 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

3. substance abuse within the past 6 months

4. high suicide risk (e.g., active suicidal ideation and/or recent intent or plan)

5. significant visual or hearing impairment

6. significant impairments in fine motor skills

7. any medical illnesses that could prevent the participant from engaging in the intervention

8. history of psychiatric hospitalization in the last 3 months

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Davis Institute

OTHER

Sponsor Role: lead

Responsible Party

Soham Rej MD, MSc

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lady Davis Institute

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36118690 (View on PubMed)

Other Identifiers

427282

Identifier Type: -

Identifier Source: org_study_id