Older Age; DepressionOMH-D RCTNCT06189118
Online MBCT vs HEP for Depressive Symptoms in Older Adults: RCT
A study testing Online Mindfulness Based Cognitive Therapy or Health Education Program in people with Older Age; Depression, run by Lady Davis Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older Age; Depression
- What is being tested?
- Online Mindfulness Based Cognitive Therapy or Health Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 2 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Verdun, Quebec, H4H 1R3
About this study
Official title: Online Mindfulness-Based Cognitive Therapy vs Health Enhancement Program for Depressive Symptoms in Older Adults: a Randomized Controlled Trial
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.
Read the detailed description
Depression in older adults is associated with increased mortality, physical comorbidity, and neurocognitive decline. Up to 50-80% of patients are resistant to pharmacotherapy. Although psychotherapies such as cognitive behavioral therapy are effective for depression, such treatments are expensive and difficult to access, often with 6-12 month wait lists in Canada. There is a need for innovative non-pharmacological treatments for depression in older adults that are scalable and potentially cost-effective. Mindfulness-Based Cognitive Therapy (MBCT) stands out as a promising solution due to its scalable group format, good tolerability, and growing evidence of its efficacy in treating depression in adults. As well, clinical and research experience since Covid has shown that older adults have been much less likely to participate in in-person behavioral interventions.
Preliminary data in LLD: Our research group completed an 8-week intervention of MBCT (as an adjunct to treatment as usual =TAU) vs. TAU in older adults with depression +/- anxiety symptoms (N=61). MBCT was superior to TAU in improving depression scores (-7.9 (±4.4) vs. -4.0 (±4.7) point change, U = 179.5, p = 0.002), with a large effect size (d = 0.86). Furthermore, the investigators have conducted a number of pilot studies, which have established that older adults can feasibly use and enjoy behavioral interventions via teleconferencing. This study is the next step for a properly powered Phase III RCT (n=100-120) with an active comparator (HEP: Health Education Program) to establish the effectiveness of this novel intervention for LLD.
Research Aims:
Primary Objective: Using an 8-week RCT, assess whether MBCT improves scores of depressive symptoms scores compared to an active control (Health Enhancement Program (HEP)). Hypothesis 1A: The MBCT group will have a lower score in the Montgomery Asberg Depression Scale (MADRS) at 8-weeks, compared to HEP controls.
Secondary Objective: To investigate the effects of MBCT on cognitive function in older adults experiencing depression. Hypothesis 2A: MBCT will lead to higher scores in executive functioning and processing speed at 8 weeks. Hypothesis 2B: The MBCT group will have higher scores of quality of life (EQ-5D) scores 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 3A: The MBCT group will have reduced scores in the Generalized Anxiety Disorder 7 (GAD-7) at 8-weeks, compared to HEP controls. Hypothesis 3B: The MBCT group will have a higher score in mindfulness presence (FFMQ), compared to HEP controls.
Methods/Expertise: This study proposes an 8-week randomized controlled trial (RCT) for participants aged 60 years and older who score 10 or more points on the Montgomery Asberg Depression Scale (MADRS). An independent researcher will randomize participants, using computer software, stratified by baseline cognitive scores (T-MoCA: 19-25 and 26+ points), 1:1 to MBCT vs. an active control (HEP), virtually delivered via teleconferencing. This study will be a blinded to allocation (rater, investigator, and clinician) RCT. The investigators will conduct assessments of 1) depression scores (primary objective), 2) quality of life (EQ5D) cognition (neurocognitive battery), and 3) anxiety (GAD-7) and mindfulness (FFMQ) before and after virtually-delivered MBCT or HEP. Outcomes will be assessed at baseline and 8 weeks. The investigators have expertise in late-life mood disorders, mindfulness clinical trials, geriatric psychiatry, cognitive assessment, and biostatistics.
(all additional details can be found by section below)
- Conditions
- Older Age; Depression
- Being tested
- Online Mindfulness Based Cognitive Therapy or Health Education Program
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness Based Cognitive Therapy or Health Education ProgramBehavioural
Also called MBCT or HEP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Online Mindfulness Based Cognitive Therapy or Health Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms scores
as measured by the Montgomery Asberg Depression Rating Scale
Measured: 8 weeks
Secondary outcomes (3)
Quality of Life scores
as measured by the EQ5D It is a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Measured: 8 weeks
Processing Speed
as measured by the Trails Making Test A and WAIS-IV Digit Symbol (SDMT)
Measured: 8 weeks
Executive Functioning
as measured by the trails Making Test B, WAIS- IV Digit Span and Verbal Fluency Test
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 posted3 Jan 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2024
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Age; DepressionStudies 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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Douglas Mental Health University Institute
- Responsible party
- Principal investigator, Soham Rej MD, MSc, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189118
- Sponsor's protocol ID
- 2024-884
- Acronym
- OMH-D RCT
- Status last verified
- May 2025
- First submitted
- 11 Sep 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD available. Group, deidentified data may be requested directly to the PI by email.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness-Based Cognitive Therapy vs Health Enhancement Program for Depressive Symptoms in Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06189118
- Acronym / sponsor ID
- OMH-D RCT / 2024-884
- Conditions
- Older Age; Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Douglas Mental Health University Institute
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 3 Jan 2024 (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.
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.
Detailed description
Depression in older adults is associated with increased mortality, physical comorbidity, and neurocognitive decline. Up to 50-80% of patients are resistant to pharmacotherapy. Although psychotherapies such as cognitive behavioral therapy are effective for depression, such treatments are expensive and difficult to access, often with 6-12 month wait lists in Canada. There is a need for innovative non-pharmacological treatments for depression in older adults that are scalable and potentially cost-effective. Mindfulness-Based Cognitive Therapy (MBCT) stands out as a promising solution due to its scalable group format, good tolerability, and growing evidence of its efficacy in treating depression in adults. As well, clinical and research experience since Covid has shown that older adults have been much less likely to participate in in-person behavioral interventions.
Preliminary data in LLD: Our research group completed an 8-week intervention of MBCT (as an adjunct to treatment as usual =TAU) vs. TAU in older adults with depression +/- anxiety symptoms (N=61). MBCT was superior to TAU in improving depression scores (-7.9 (±4.4) vs. -4.0 (±4.7) point change, U = 179.5, p = 0.002), with a large effect size (d = 0.86). Furthermore, the investigators have conducted a number of pilot studies, which have established that older adults can feasibly use and enjoy behavioral interventions via teleconferencing. This study is the next step for a properly powered Phase III RCT (n=100-120) with an active comparator (HEP: Health Education Program) to establish the effectiveness of this novel intervention for LLD.
Research Aims:
Primary Objective: Using an 8-week RCT, assess whether MBCT improves scores of depressive symptoms scores compared to an active control (Health Enhancement Program (HEP)). Hypothesis 1A: The MBCT group will have a lower score in the Montgomery Asberg Depression Scale (MADRS) at 8-weeks, compared to HEP controls.
Secondary Objective: To investigate the effects of MBCT on cognitive function in older adults experiencing depression. Hypothesis 2A: MBCT will lead to higher scores in executive functioning and processing speed at 8 weeks. Hypothesis 2B: The MBCT group will have higher scores of quality of life (EQ-5D) scores 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 3A: The MBCT group will have reduced scores in the Generalized Anxiety Disorder 7 (GAD-7) at 8-weeks, compared to HEP controls. Hypothesis 3B: The MBCT group will have a higher score in mindfulness presence (FFMQ), compared to HEP controls.
Methods/Expertise: This study proposes an 8-week randomized controlled trial (RCT) for participants aged 60 years and older who score 10 or more points on the Montgomery Asberg Depression Scale (MADRS). An independent researcher will randomize participants, using computer software, stratified by baseline cognitive scores (T-MoCA: 19-25 and 26+ points), 1:1 to MBCT vs. an active control (HEP), virtually delivered via teleconferencing. This study will be a blinded to allocation (rater, investigator, and clinician) RCT. The investigators will conduct assessments of 1) depression scores (primary objective), 2) quality of life (EQ5D) cognition (neurocognitive battery), and 3) anxiety (GAD-7) and mindfulness (FFMQ) before and after virtually-delivered MBCT or HEP. Outcomes will be assessed at baseline and 8 weeks. The investigators have expertise in late-life mood disorders, mindfulness clinical trials, geriatric psychiatry, cognitive assessment, and biostatistics.
(all additional details can be found by section below)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online Mindfulness based Cognitive Therapy | Experimental | Behavioral: Online Mindfulness Based Cognitive Therapy or Health Education ProgramThe intervention will consist of 8 online weekly sessions (90-min each) of Mindfulness based Cognitive Therapy, plus daily home practice. |
| Online Health Education Program | Active comparator | Behavioral: Online Mindfulness Based Cognitive Therapy or Health Education ProgramThe active control will consist of 8 online weekly sessions (90-min each) of Health Education Program, plus daily home practice. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Online Mindfulness Based Cognitive Therapy or Health Education ProgramAlso: MBCT or HEP12 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. | Behavioural | Online Health Education Program, Online Mindfulness based Cognitive Therapy |
Primary outcome
Depressive symptoms scores
Time frame: 8 weeks
as measured by the Montgomery Asberg Depression Rating Scale
3 secondary outcomes
Quality of Life scores
Time frame: 8 weeks
Processing Speed
Time frame: 8 weeks
Executive Functioning
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No. No IPD available. Group, deidentified data may be requested directly to the PI by email.
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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 Online Mindfulness Based Cognitive Therapy or Health Education Program in people with Older Age; Depression, 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 6 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: finished, as of the sponsor's last update on 25 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depressive symptoms scores (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.