Mindfulness-Based Therapy for Serious Mental Illness
(MBT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of mindfulness-based therapy (MBT) for individuals with serious mental illnesses such as schizophrenia and major mood disorders. It will compare regular treatment alone to regular treatment combined with MBT, which integrates mindfulness exercises with cognitive-behavioral techniques to help manage the illness. Conducted in community mental health centers across the U.S., the study seeks to establish MBT as a common part of mental health care if proven helpful. The trial seeks participants diagnosed with schizophrenia or a major mood disorder who are already receiving care at a community mental health center. As an unphased trial, it offers participants the chance to contribute to pioneering research that could enhance mental health care practices.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment while participating, as the trial involves adding mindfulness-based therapy to your existing care.
What prior data suggests that mindfulness-based therapy is safe for patients with serious mental illness?
Research has shown that mindfulness-based therapy (MBT) is safe for individuals with serious mental health conditions such as schizophrenia and major mood disorders. Studies have found that MBT can reduce the likelihood of hospitalization or emergency service use, potentially helping individuals remain stable and avoid hospital visits. Other research suggests that group mindfulness sessions can improve symptoms of schizophrenia and depression. Overall, MBT appears to be well-received and beneficial for mental health without causing serious side effects.12345
Why are researchers excited about this trial?
Mindfulness-based therapy is unique because it focuses on enhancing present-moment awareness and acceptance, which is different from traditional treatments for serious mental illness like pharmacotherapy and standard psychotherapy. Most treatments aim to manage symptoms through medication or traditional talk therapy, while mindfulness-based therapy empowers patients by teaching them skills to manage stress and emotions in real-time. Researchers are excited about this approach because it has the potential to improve mental well-being without the side effects often associated with medication, offering a holistic complement to existing treatment options.
What evidence suggests that mindfulness-based therapy might be an effective treatment for serious mental illness?
Research has shown that mindfulness-based therapy (MBT), which participants in this trial may receive, can help individuals with serious mental illness (SMI) feel and function better. Studies from the United Kingdom have found that MBT aids people living in the community in managing their conditions more effectively. Specifically, MBT has reduced symptoms of depression and anxiety, common in SMI. It combines mindfulness exercises with strategies to change thinking patterns, assisting individuals in managing their illness. Moreover, MBT has succeeded even in everyday healthcare settings, suggesting it could be widely adopted. This evidence supports the idea that MBT could be a helpful treatment for those with SMI.15678
Who Is on the Research Team?
Brandon Gaudiano, PhD
Principal Investigator
Butler Hospital
Are You a Good Fit for This Trial?
This trial is for adults with serious mental illnesses like schizophrenia, major depression, or bipolar disorder. Participants must be receiving care at a community mental health center and able to undergo mindfulness-based therapy alongside their usual treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Mindfulness-Based Therapy (MBT) in a group format for 12 weeks
Midpoint Assessment
Blinded assessments conducted to evaluate progress at the midpoint of the treatment
Post-Treatment Assessment
Blinded assessments conducted to evaluate outcomes immediately after treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mindfulness-Based Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Butler Hospital
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator