Depression in Old AgeNCT05366088
RCT of MBCT vs HEP for Late-Life Depression
A study testing Mindfulness-Based Cognitive Therapy and Health Enhancement Program in people with Depression in Old Age and Quality of Life, run by Lady Davis Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Depression in Old Age, Quality of Life
- What is being tested?
- Mindfulness-Based Cognitive Therapy and Health Enhancement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-Based Cognitive Therapy (MBCT) vs. Health Enhancement Program (HEP) Active Control for Late-Life Depression: An RCT
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.
Read the 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
- Being tested
- Mindfulness-Based Cognitive Therapy, Health Enhancement Program
- Keywords
- Late-life depression, Quality of Life, Mindfulness-Based Cognitive Therapy, Behavioural Activation, Executive Functioning, Processing Speed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Health Enhancement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS) score
Depression Symptoms, score results suggest mild, moderate or sever depression
Measured: 8 weeks
Secondary outcomes (1)
Quality of Life 5 dimensions
is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 May 2025
Why it stopped: Double record
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soham Rej MD, MSc, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366088
- Sponsor's protocol ID
- 427282
- Status last verified
- May 2025
- First submitted
- 26 Apr 2022
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36118690
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Therapy (MBCT) vs. Health Enhancement Program (HEP) Active Control for Late-Life Depression: An RCT
- ClinicalTrials.gov ID
- NCT05366088
- Acronym / sponsor ID
- 427282
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Double record
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyOnline 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). |
| Health Enhancement Program | Active comparator | Behavioral: Health Enhancement ProgramOnline 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive TherapyMBCT 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. | Behavioural | Mindfulness-Based Cognitive Therapy |
| Health Enhancement ProgramHEP 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. | Behavioural | Health Enhancement Program |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS) score
Time frame: 8 weeks
Depression Symptoms, score results suggest mild, moderate or sever depression
1 secondary outcome
Quality of Life 5 dimensions
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Double record). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 36118690Bein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy and Health Enhancement Program in people with Depression in Old Age and Quality of Life, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Double record). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale (MADRS) score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.