Mindfulness-Based Therapy for Serious Mental Illness
(MBT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Serious mental illness (SMI), encompassing schizophrenia-spectrum and major mood disorders, has been estimated to affect approximately 5.4% of the U.S. adult population each year. Research shows low rates of evidence-based treatment being provided to patients with SMI. This is unfortunate, because evidence-based psychological therapies have been shown to be effective for improving outcomes in SMI. One such efficacious psychological intervention is mindfulness-based therapy (MBT), which integrates mindfulness practice with cognitive-behavioral strategies to improve illness management. Previous trials conducted in the United Kingdom have shown that MBT improves symptoms and functioning in community-based outpatients with SMI, including in routine practice settings. In the U.S., most patients with SMI receive treatment at local community mental health centers (CMHCs). However, patients in CMHCs often cannot access evidence-based therapies like MBT due to the lack of trained staff able to provide these interventions. Further, previous studies of MBT have been conducted exclusively outside the U.S. It is essential to confirm that MBT is effective when delivered for patients with SMI in the U.S., and how it can be sustainably implemented in CMHCs where this clinical population is commonly treated. Thus, the investigators propose to test the effectiveness of MBT for SMI and study its implementation in a typical CMHC setting. The investigators will randomize 160 patients with SMI (psychotic-spectrum and major mood disorders) to receive treatment as usual (TAU) vs TAU plus MBT delivered by frontline clinicians in a large, diverse CMHC. The investigators will conduct blinded assessments at baseline and at 6- (mid), 12- (post), and 24-weeks (follow-up). Consistent with an experimental therapeutics approach, the investigators will examine potential mechanisms of action (e.g., mindfulness skills), as well as collect implementation-focused quantitative and qualitative data from our community partners (patients, administrators, clinicians). If found to be effective and aided by a certified training program and the implementation data collected, MBT could be adopted as a future evidence-based practice and integrated into the routine community care of patients with SMI, thereby reducing health disparities.
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.
Is mindfulness-based therapy safe for people with mental health conditions?
Mindfulness-based therapies, like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), are generally considered safe and have been used as additional treatments for conditions like depression and PTSD. They are described as safe, portable, and cost-effective, making them suitable as an adjunct to standard care.12345
How is Mindfulness-Based Therapy different from other treatments for serious mental illness?
Mindfulness-Based Therapy is unique because it focuses on helping individuals become more aware of the present moment and their thoughts and emotions, which can change their relationship with these experiences. Unlike some other treatments, it often requires home practice and can be done individually or in groups, providing practical tools for ongoing life challenges.678910
What data supports the effectiveness of the treatment Mindfulness-Based Therapy for serious mental illness?
Research shows that mindfulness-based therapies can improve psychological quality of life and reduce distress in people with severe mental illnesses. These therapies have been found to be beneficial for conditions like depression and anxiety, and they help individuals manage unhelpful thoughts and emotions.6891112
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