What side effects are associated with this type of intervention?

Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) are generally well-tolerated with minimal side effects. Some individuals may experience temporary increases in anxiety or emotional discomfort as they confront distressing thoughts and feelings. Lifestyle practices such as regular exercise can lead to muscle soreness, fatigue, or injury if not done properly. Overall, these treatments are considered safe and effective for managing depression with fewer side effects compared to pharmacological options.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine and venlafaxine, and atypical antidepressants like bupropion. These medications are often used in combination with psychotherapies such as Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) to enhance treatment outcomes. While MBCT itself is not a medication, it is a structured program that combines mindfulness practices with cognitive therapy techniques to prevent depression relapse and promote overall mental well-being.

What other types of research exist?

Promising novel alternatives to the MBCT Maintenance Program for depression patients include: 1) Digital Cognitive Behavioral Therapy (CBT) platforms, which offer flexibility and accessibility; 2) Acceptance and Commitment Therapy (ACT), which focuses on psychological flexibility and value-based living; 3) Integrative approaches combining physical exercise with mindfulness practices, such as yoga or tai chi; 4) Positive Psychology Interventions (PPIs) that emphasize building positive emotions, engagement, and meaning; and 5) Biofeedback and neurofeedback therapies that enhance interoceptive awareness and self-regulation.

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Mindfulness Based Cognitive Therapy for Depression (OMM Trial)

N/A

Waitlist Available

Led By Frederick Hecht, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 months change

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a follow-up program for people who finished a mindfulness therapy course to prevent depression from returning. It includes extra classes and regular check-ins to help them keep using their skills. The goal is to reduce the chances of depression coming back. Mindfulness-based cognitive therapy (MBCT) is a class-based program designed to prevent relapse or recurrence of major depression.

Who is the study for?

This trial is for adults over 18 in the US who have finished a Mindfulness-Based Cognitive Therapy (MBCT) program, primarily to manage depression. Participants must be able to attend virtual classes via smartphone or other devices and speak and read English.

What is being tested?

The study tests an MBCT maintenance program designed to prevent depression relapse. It includes a booster course with weekly sessions for four weeks, then monthly follow-ups focusing on mindfulness, positive emotions, reaction management, self-care, sleep, diet, and relationships.

What are the potential side effects?

As this intervention involves psychological practices rather than medication or medical procedures, side effects may include emotional discomfort or distress during mindfulness exercises but are generally considered low-risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 months change

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 months change

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 months change for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Experiences Questionnaire scores

Change in Five Facet Mindfulness Questionnaire-short form (FFMQ-sf) scores

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8a scores

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness maintenance programExperimental Treatment1 Intervention

Participants receive: (1) Four-week course to strengthen and extend skills learned in 8-week MBCT course, (2) Monthly 1.5 hour meeting session, and (3) Monthly check-in survey.

Group II: Wait-listActive Control1 Intervention

Participants receive follow-up measures but no intervention until the end of the wait-list period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness maintenance program

2023

N/A

~40

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness-Based Cognitive Therapy (MBCT) combines mindfulness practices with cognitive behavioral techniques to help patients become more aware of their thoughts and feelings and to develop a non-judgmental attitude towards them. This enhances interoceptive awareness and helps in reducing rumination, a common feature in depression. Cognitive Behavioral Therapy (CBT) focuses on identifying and changing negative thought patterns and behaviors, thereby improving mood and emotional regulation. Exercise and healthy lifestyle practices, such as proper diet and sleep, contribute to overall well-being by reducing stress, improving physical health, and boosting positive emotions. These mechanisms are crucial for depression patients as they address both the psychological and physiological aspects of the disorder, promoting a holistic approach to treatment and potentially reducing the risk of relapse.