Mindfulness-Based Therapy for Depression

(MAT Process Trial)

Overseen By Morganne Kraines, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Butler Hospital

Disqualifiers: Psychotic symptoms, Hazardous alcohol/drug use, others

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapy approaches to help manage depression. It compares Mindfulness-Based Cognitive Therapy (MBCT), which includes meditation and cognitive exercises, with a Wellness program that addresses health topics like nutrition and sleep without focusing on emotional thinking. The researchers aim to assess how these treatments affect emotional control and decision-making in individuals with mild depression symptoms. English-speaking adults with mild to moderate depression who haven't tried mindfulness therapy before may find this trial suitable. Participants will complete surveys, participate in interviews, and engage in computer tasks to measure progress. As an unphased trial, it offers participants the chance to contribute to innovative research on depression management strategies.

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

The trial does not require you to stop taking your current medications, but you must not have changed your psychiatric medications in the last 4 weeks before joining.

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

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT) is generally safe for people with depression. Studies have found that MBCT is well-tolerated, even for those who haven't succeeded with other treatments. It has been used safely in many settings, reducing stress and improving mental health without major side effects.

The Wellness for Wellbeing program addresses general health topics like nutrition and sleep. Since it emphasizes education rather than medical treatments, it is also considered safe. Participants engage in discussions and activities that are unlikely to cause harm.

Overall, both MBCT and the Wellness for Wellbeing program support mental health without posing significant risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindfulness-Based Cognitive Therapy (MBCT) for depression because it offers a unique approach by combining cognitive therapy techniques with meditation exercises. Unlike standard treatments like antidepressants or traditional cognitive-behavioral therapy, MBCT emphasizes mindfulness, encouraging participants to become more aware of their thoughts and feelings in the present moment. This approach may help individuals better manage depressive symptoms by changing their relationship to negative thoughts rather than directly altering the thoughts themselves. Additionally, MBCT includes a daily home practice and a full-day meditation retreat, providing a comprehensive and immersive experience that could lead to long-lasting changes in mental health.

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

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT), one of the treatments in this trial, works well for people with depression. Studies have found that MBCT helps reduce repetitive, negative thoughts and improves control over emotions. It also decreases the likelihood of depression returning over time. Those who have tried MBCT report better mindfulness skills and continue to feel the benefits even months after finishing treatment. Overall, MBCT is a strong option for managing depression, especially for those who haven't found success with other treatments. Participants in this trial may also be assigned to the Wellness for Wellbeing arm, which serves as an active control and focuses on general health topics. ^{2 6 7 8 9}

Who Is on the Research Team?

Morganne Kraines, PhD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking adults (18+) with mild to moderate depression, who have had a major depressive episode in the last 5 years but are not currently experiencing severe symptoms or a major episode. Participants should not be undergoing recent changes in psychotherapy or medication, and must not have prior mindfulness-based treatment experience.

Inclusion Criteria

I am not experiencing symptoms of a manic episode.

I do not have symptoms like hallucinations or delusions that affect my daily life.

I have never participated in mindfulness-based stress reduction or cognitive therapy.

Exclusion Criteria

Previous enrollment in MBCT or MBSR

My psychiatric medication has not changed in the last 4 weeks.

Formally diagnosed learning disability, intellectual disability, or other developmental disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Orientation

Participants receive an orientation to either MBCT or Wellness for Wellbeing

1-2 weeks

1 visit (in-person)

Treatment

Participants attend either MBCT or Wellness for Wellbeing classes

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in affective executive functioning and depression symptoms

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-Based Cognitive Therapy
• Wellness for Wellbeing

Trial Overview

The study compares Mindfulness-Based Cognitive Therapy (MBCT) with Wellness for Wellbeing to see how they affect mood and thought processes related to emotions. It uses random assignment to either intervention and measures outcomes through tasks that assess emotional control like inhibition, updating, and shifting.

How Is the Trial Designed?

Group I: Mindfulness-Based Cognitive Therapy (MBCT) Experimental Treatment 1 Intervention

MBCT classes are comprised of weekly, 2.5-hour classes in which participants learn cognitive therapy techniques and practice meditation exercises. Participants will complete group and/or individual orientation to MBCT with the MBCT instructor, 1-2 weeks prior to the first scheduled MBCT class. Additionally, MBCT requires 45-minutes of daily home practice, and a full day, 8-hour silent meditation retreat. MBCT classes are delivered via the protocol and curriculum developed by the MBCT founders. Participants randomized to MBCT will receive 8-weeks of MBCT classes.

Group II: Wellness for Wellbeing Active Control 1 Intervention

Wellness for Wellbeing will serve as the active control for MBCT. Participants randomized to Wellness for Wellbeing will receive 1-hour group delivered classes, once per week, for 8-weeks. Participants will receive an orientation to Wellness for Wellbeing 1-2 weeks prior to the first class. Classes will be delivered by a research therapist. Topics for Wellness for Wellbeing include: nutrition, caffeine, preventing cancer, diabetes, heart health, sleep, being a smart patient, and complementary and alternative medicine. Wellness for Wellbeing classes are interactive and do not include components designed to impact affective cognition in any way. Because participants may have varying levels of health literacy, the research therapist tailors presentation of the material to the participants' level of knowledge of the topic. Information presented in Wellness for Wellbeing is regularly updated with current health guidelines.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Mindfulness-based cognitive therapy (MBCT) is recognized as an effective psychotherapeutic intervention that combines cognitive behavioral therapy with mindfulness meditation, specifically aimed at preventing recurrent major depressive disorder.

Over the past fifteen years, MBCT has gained significant attention and is now recommended in various national clinical guidelines for its potential to prevent depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. Velden, AM., Piet, J., Møller, AB., et al.[2018]

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]

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 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) 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 reducing the risk of depressive relapse by increasing mindfulness and decreasing negative repetitive thoughts, which are key mechanisms of change.

Current research highlights the need for more rigorous comparisons with control conditions to better understand MBCT's specific effects, as well as challenges in training therapists and spreading the therapy more widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for depression: trends and developments. MacKenzie, MB., Kocovski, NL.[2020]

Citations

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