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

Trial Summary

What is the purpose of this trial?

The primary objective for this project is to test whether affective executive functioning is a mechanism of action of mindfulness-based cognitive therapy and Wellness for Wellbeing. The main questions it aims to answer are: 1. Test the effect of MBCT vs. Wellness for Wellbeing on affective inhibition (i.e., emotionally valenced inhibition as measured via the affective Go/No Go task) using an RCT. 2. Test the effect of MBCT vs. Wellness for Wellbeing on (a) affective updating and (b) affective shifting. Outcomes will be measured with the affective n-Back and the affective Internal Switching Task, respectively. 3a) The investigators will examine whether depression symptom severity co-varies with change in affective executive functioning (i.e., affecting inhibition, shifting, and updating) over time. 3b) The investigators will examine whether compliance with treatment protocol (e.g., number of classes attended, amount of home practice) predicts endpoint executive functioning. Participants will complete surveys, interviews, and computer tasks, and will be randomized to either Mindfulness-Based Cognitive Therapy or Wellness for Wellbeing.

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.

What data supports the idea that Mindfulness-Based Therapy for Depression is an effective treatment?

The available research shows that Mindfulness-Based Therapy for Depression (MBCT) is effective in reducing the chances of depression coming back. One study found that MBCT helps prevent relapse in people with major depressive disorder. Another study noted that while MBCT is effective, about one-third of people might still experience a relapse within a year. Overall, MBCT is recommended in several national guidelines as a preventative treatment for recurring depression, showing its effectiveness compared to other treatments. ^{1 2 3 4 5}

What safety data exists for mindfulness-based therapy for depression?

The research indicates that mindfulness-based cognitive therapy (MBCT) is primarily focused on preventing depression relapse and has been applied to other mental disorders. While the studies emphasize its effectiveness, particularly in reducing relapse rates in major depressive disorder, they do not explicitly detail safety data. However, the consistent application and study of MBCT in clinical settings suggest a level of safety, though specific safety outcomes are not highlighted in the provided abstracts. ^{1 2 3 5 6}

Is Mindfulness-Based Cognitive Therapy a promising treatment for depression?

Yes, Mindfulness-Based Cognitive Therapy (MBCT) is a promising treatment for depression. It combines mindfulness meditation with cognitive therapy techniques to help prevent depression from coming back. Research shows it is effective in reducing the chances of depression relapse, making it a valuable option for those at risk of recurring depression. ^{1 2 3 4 5}

Research Team

Morganne Kraines, PhD

Principal Investigator

Butler Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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 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 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) 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]

References

1. 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]

2. 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]

3. 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]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018]

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

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

6. New Zealand pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for depression: trends and developments. [2020]