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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two online treatments for depression in older adults: Mindfulness-Based Cognitive Therapy (MBCT) and a Health Enhancement Program (HEP). Both treatments include 8 weekly Zoom sessions and daily practice at home. The researchers aim to determine which treatment more effectively improves depression and thinking skills in individuals aged 60 and above. Ideal participants are those experiencing moderate to severe depression, have internet access, and can comfortably use digital devices. As an unphased trial, this study allows participants to contribute to innovative research that could enhance mental health care for older adults.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that mindfulness-based cognitive therapy (MBCT) is generally safe for treating depression. Research has found that MBCT effectively reduces symptoms of depression and anxiety, whether offered in group sessions or over the phone.

Research indicates that participants tolerate MBCT well, with few reports of negative side effects. This makes it a promising option for those seeking treatments without medication.

The Health Enhancement Program (HEP) used in the study serves as a comparison and focuses on general health education. Although specific safety data for HEP isn't detailed, educational programs like this are usually low-risk and safe for participants.

Overall, both MBCT and HEP offer safe and potentially helpful options for managing depression in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for depression, which often involve medication or face-to-face therapy, the online Mindfulness-Based Cognitive Therapy (MBCT) offers a unique approach by combining mindfulness practices with cognitive therapy all delivered online. This means participants can engage in therapy from the comfort of their own homes, making it more accessible and convenient. Additionally, MBCT focuses on helping individuals become more aware of their thoughts and feelings in the present moment, potentially reducing the risk of relapse by equipping them with mindfulness skills. Researchers are excited about this because it provides a flexible, potentially more engaging alternative to conventional methods while maintaining the effectiveness of traditional cognitive therapies.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that online Mindfulness-Based Cognitive Therapy (MBCT), a treatment in this trial, effectively reduces depression symptoms. Studies have found that participants with depression in online MBCT groups experienced significant improvements in their mood. One study even found that online MBCT lowered both anxiety and depression levels. This suggests MBCT could be a promising non-medication treatment for depression in later life. Another treatment arm in this trial is the Online Health Education Program (HEP), which serves as an active comparator. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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 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]

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