Online MBCT vs HEP for Depressive Symptoms in Older Adults: RCT

NCT06189118 | Completed

• 1 other identifier: 2024-884
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

In Canada, depression affects more than 300,000 adults over the age of 60, which costs the healthcare system an estimated $5 billion each year. Late-life depression (LLD) is associated with more deaths, more physical and mental health problems. LLD is hard to treat, as many people will not respond to treatment and many will stop taking antidepressant medication due to negative side-effects. Unfortunately, common non-medication treatments like cognitive behavioral therapy are often inaccessible because of long (6-12 months) wait times and high costs. In a previous study, we found that an 8-week group mindfulness-based cognitive therapy (MBCT) program improved depressive symptoms more than regular LLD treatment (i.e. antidepressants and/or support counseling). Now, a larger scale study is required to compare MBCT to an active control group. Furthermore, research and clinical experience during and post-Covid pandemic has shown that older adults are nowadays far less likely to participate in in-person intervention studies but appreciate and tolerate Zoom delivery of behavioral interventions. This study will compare the effects of MBCT versus an active control group, Health Enhancement Program (HEP), both delivered by Zoom, to see if it improves symptoms of depression in older adults. The study team plans to recruit approximately 100-120 participants in across Canada, who will be randomly assigned to 8-weeks of either MBCT or HEP, delivered by Zoom. The investigators will observe if these treatments improve depression as well as cognition by conducting in-person cognitive assessments. Currently there is a lack of affordable and accessible non-medication treatments for LLD that can be scaled to reach many people. If successful, Mindfulness may be a potential solution, as it is easily given in groups and is well-tolerated by older adults with LLD.

Conditions

Older Age; Depression

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms scores

  as measured by the Montgomery Asberg Depression Rating Scale

  8 weeks

Secondary Outcomes (3)

• Quality of Life scores

  8 weeks

• Processing Speed

  8 weeks

• Executive Functioning

  8 weeks

Other Outcomes (2)

• Exploratory outcomes: anxiety scores

  8 weeks

• Exploratory outcome: Mindfulness Presence Scores

  8 weeks

Study Arms (2)

Online Mindfulness based Cognitive Therapy

EXPERIMENTAL

The intervention will consist of 8 online weekly sessions (90-min each) of Mindfulness based Cognitive Therapy, plus daily home practice.

Behavioral: Online Mindfulness Based Cognitive Therapy or Health Education Program

Online Health Education Program

ACTIVE COMPARATOR

The active control will consist of 8 online weekly sessions (90-min each) of Health Education Program, plus daily home practice.

Behavioral: Online Mindfulness Based Cognitive Therapy or Health Education Program

Interventions

Online Mindfulness Based Cognitive Therapy or Health Education Program BEHAVIORAL

12 hours of online group training of Mindfulness Based Cognitive Therapy OR 12 hours of online group training of Health Education Program will be provided via teleconferencing. Additional both groups will perform daily home practice.

Also known as: MBCT or HEP

Online Health Education Program; Online Mindfulness based Cognitive Therapy

Eligibility Criteria

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

You may qualify if:

• 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.)
• MADRS score ≥ 10 (experiencing symptoms of moderate/severe depression) at baseline.
• 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 T-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
• Douglas Mental Health University Institute: collaborator

Study Sites (1)

Douglas Mental Health University Institute

Verdun, Quebec, H4H 1R3, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator and outcome assessors will not be aware of allocation. Randomization and allocation will be conducted by an independent statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Geriatric Psychiatrist, Principal Investigator

Model Details: A Randomized Controlled Clinical Trial (n=100-120) older adults aged 60 and over who experience symptoms of depression (MADRS score 10 and more) and provide written consent will go through 1:1 stratified randomization (stratified cognition by Telephone-Montreal Cognitive Assessment, T-MoCA 19-25 and 26+points). The intervention will consist of 8 online sessions (90-min each) of Mindfulness based Cognitive Therapy. The active control will consist of 8 online sessions (90-min each) of Health Education Program. Participants in both study arms will continue with their usual antidepressant therapy and/or psychosocial care. Primary outcome: depressive symptoms; Secondary outcome: quality of life and cognition; Exploratory outcomes: anxiety and mindfulness presence. Baseline (weeks -2 to 0) and post-intervention (weeks 8-10) assessments will be conducted.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: January 3, 2024
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 2, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)