Mindfulness-Based Therapy for Depression

(MAT Process Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Morganne Kraines, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Butler Hospital

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

No Placebo Group

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}

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

Trial 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 (Behavioral Intervention)
• Wellness for Wellbeing (Behavioral Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Butler Hospital Providence, RI

Who Is Running the Clinical Trial?

Butler Hospital Lead Sponsor

National Center for Complementary and Integrative Health (NCCIH) Collaborator

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] Mindfulness-based cognitive therapy (MBCT) is a group-based clinical intervention program designed to reduce relapse or recurrence of major depressive disorder (MDD) by means of systematic training in mindfulness meditation combined with cognitive-behavioral methods.

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] Mindfulness-based cognitive therapy (MBCT) is an effective group intervention for reducing rates of depression relapse. However, about one-third of graduates experience relapse within 1 year of completing the course.

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] Mindfulness-based cognitive therapy (MBCT) is a programme developed to prevent depression relapse, but has been applied for other disorders. Our objective was to systematically review and meta-analyse the evidence on the effectiveness and safety of MBCT for the treatment of mental disorders.

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

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018] Mindfulness-based cognitive therapy (MBCT) is an evidence-based psychotherapeutic intervention, which integrates elements of cognitive behavioural therapy for depression with the clinical application of mindfulness meditation. MBCT is currently recommended in several national clinical guidelines as a preventative treatment for recurrent major depressive disorder. Over the last fifteen years there has been a growing interest in MBCT and its clinical potential in the prevention of depressive episodes. In this article, we review the current status of the research in the field.

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

Mindfulness-based cognitive therapy: a promising new approach to preventing depressive relapse. [2022] Mindfulness-based cognitive therapy (MBCT) was developed as a psychological approach for people at risk for depressive relapse who wish to learn how to stay well in the long-term. In this article we set out the rationale for MBCT, outline the treatment approach, overview the efficacy research to date and look to future challenges.

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

Mindfulness-based cognitive therapy for depression: trends and developments. [2020] Mindfulness-based cognitive therapy (MBCT) was developed as a psychological intervention for individuals at risk of depressive relapse. Possible mechanisms of change for this intervention are in line with its theoretical underpinnings, and include increases in mindfulness and/or decreases in negative repetitive thoughts. This review provides an overview of current trends in MBCT research, including efficacy and questions regarding the specific effects of MBCT in light of recent comparisons with structurally equivalent control conditions, mechanisms of change, and moderators of treatment outcome. In addition, future directions are discussed, such as challenges with training an adequate number of therapists and disseminating this therapy.