Online MBCT vs HEP for Depression

(OMH-D RCT Trial)

Overseen By Myriam Lesage, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: Cognitive deficits, PTSD, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this 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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must inform the study team if there are any changes to your psychotropic medications and dosage during the first 8 weeks of the study.

What data supports the idea that Online MBCT vs HEP for Depression is an effective treatment?

The available research shows that Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing depressive symptoms and preventing depression relapse. One study found that MBCT is a promising intervention for reducing depressive symptoms, with participants reporting lower depression and anxiety scores after completing the program. Another study highlighted that MBCT can help prevent depression relapse, although some participants may still experience relapse within a year. While the research does not directly compare Online MBCT to the Health Education Program (HEP) for depression, it suggests that MBCT is beneficial for managing depression and could be a viable treatment option. ^{1 2 3 4 5}

What safety data exists for Online MBCT and HEP for depression?

The safety of Mindfulness-Based Cognitive Therapy (MBCT), including its online and telephone-delivered versions, has been evaluated in several studies. A systematic review and meta-analysis of MBCT for mental disorders, including depression, assessed its effectiveness and safety. An open trial of telephone-delivered MBCT reported no adverse events or additional need for mental health treatment, indicating its safety for reducing depressive and anxiety symptoms. Overall, MBCT is considered safe, with no significant safety concerns reported in the studies reviewed. ^{1 2 4 6 7}

Is the treatment HEP, Online MBCT a promising treatment for depression?

Yes, Online MBCT is a promising treatment for depression. It helps prevent depression from coming back and reduces symptoms. It is also well-received by participants and can be delivered in different ways, like over the phone, making it more accessible. ^{1 2 4 7 8}

Eligibility Criteria

This trial is for Canadian adults over 60 with depression, who may have found traditional treatments like medication and therapy inaccessible or ineffective. Participants must be able to use Zoom for online sessions but cannot join if they are currently receiving other psychological therapies.

Inclusion Criteria

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

Adequate understanding of English or French.

I can sit for 90 minutes without feeling uncomfortable.

Exclusion Criteria

History of psychiatric hospitalization in the last 3 months

I have major problems with my vision or hearing.

I have trouble with tasks that require small, precise movements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mindfulness-Based Cognitive Therapy (MBCT) or Health Enhancement Program (HEP) over 8 weeks, delivered via Zoom

8 weeks

8 online weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HEP
• Online MBCT

Trial Overview The study compares two non-medication treatments delivered via Zoom: Mindfulness Based Cognitive Therapy (MBCT) and a Health Education Program (HEP). Each lasts 8 weeks, aiming to see which better improves depressive symptoms and cognition in older adults.

Participant Groups

Group I: Online Mindfulness based Cognitive Therapy Experimental Treatment 1 Intervention

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

Group II: Online Health Education Program Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Douglas Mental Health University Institute

Collaborator

Trials

31

Recruited

2,800+

Findings from Research

The abbreviated, telephone-delivered mindfulness-based cognitive therapy (MBCT-T) program was found to be feasible and acceptable, with 64% of participants attending at least 4 sessions and 71% completing all assigned home practices.

Participants experienced significant reductions in depressive symptoms (4.09 points lower) and anxiety (3.18 points lower) after the 8-week program, indicating preliminary efficacy for this intervention in individuals with chronic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open Trial of Telephone-Delivered Mindfulness-Based Cognitive Therapy: Feasibility, Acceptability, and Preliminary Efficacy for Reducing Depressive Symptoms. Shallcross, AJ., Duberstein, ZT., Sperber, SH., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Guided self-help mindfulness-based interventions (GSH-MBIs) significantly reduce psychological distress and improve sleep quality in patients with hepatocellular carcinoma, based on a study of 122 participants.

The improvements in psychological distress and sleep quality were linked to increased psychological flexibility and reduced perceived stress, indicating that these factors mediate the effectiveness of GSH-MBIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of guided self-help intervention based on mindfulness for patients with hepatocellular carcinoma: effects and mechanisms. Liu, Z., Li, M., Jia, Y., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

A review of 20 studies identified key barriers to adherence to Mindfulness-Based Cognitive Therapy (MBCT) for patients with chronic conditions, including practical factors like time commitments and motivation levels.

Facilitators for adherence included strong connections with group members and the credibility of the intervention, suggesting that addressing these factors could improve patient engagement and outcomes in MBCT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the barriers and facilitators to adherence to mindfulness-based cognitive therapy for those with chronic conditions. Marks, E., Moghaddam, N., De Boos, D., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) is designed specifically for individuals at risk of depressive relapse, helping them learn strategies to maintain long-term mental wellness.

The article reviews existing research on the effectiveness of MBCT, highlighting its potential as a valuable psychological intervention for preventing future episodes of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. Williams, JM., Kuyken, W.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the risk of relapse or recurrence of major depressive disorder (MDD) by 34%, based on a meta-analysis of six randomized controlled trials involving 593 participants.

For patients with three or more previous episodes of MDD, MBCT offers a 43% reduction in relapse risk and is at least as effective as maintenance antidepressant medication, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Piet, J., Hougaard, E.[2022]

Mindfulness-based Cognitive Therapy (MBCT) is effective in helping participants with depression develop skills, increase awareness, and gain a sense of agency over their experiences, as shown in a systematic review of 21 qualitative studies.

Participants reported a mix of acceptance and ambivalence towards their mindfulness practices, indicating that while MBCT can lead to meaningful change, it may also present challenges for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. Williams, K., Hartley, S., Langer, S., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Open Trial of Telephone-Delivered Mindfulness-Based Cognitive Therapy: Feasibility, Acceptability, and Preliminary Efficacy for Reducing Depressive Symptoms. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of guided self-help intervention based on mindfulness for patients with hepatocellular carcinoma: effects and mechanisms. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review of the barriers and facilitators to adherence to mindfulness-based cognitive therapy for those with chronic conditions. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-ethnographic synthesis of Mindfulness-based Cognitive Therapy for people with major depression. [2023]