Mindfulness-Based Therapy for Serious Mental Illness
(MBT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBrandon Gaudiano, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Butler Hospital

No Placebo Group

Trial Summary

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, we propose to test the effectiveness of MBT for SMI and study its implementation in a typical CMHC setting. Additionally we will specify a certified training program in MBT for frontline clinicians, given the differences between U.K. and U.S. healthcare systems. To speed translation to clinical practice, we also will collect information from diverse community partners on implementation barriers and facilitators to promote future uptake. We 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. We will conduct blinded assessments at baseline and at 6- (mid), 12- (post), and 24-weeks (follow-up). Consistent with an experimental therapeutics approach, we 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.

Eligibility Criteria

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

Ability to speak and read English

I am 18 years old or older.

I am currently getting mental health treatment at a community center.

+1 more

Exclusion Criteria

Not clinically stable enough to participate in treatment

I practice mindfulness weekly.

Participant Groups

The study tests if adding mindfulness-based therapy (MBT) to the standard treatment helps people with serious mental illness. It compares patients' progress between those who get MBT plus usual care versus just usual care over a period of up to 24 weeks.

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-based therapyExperimental Treatment1 Intervention

Mindfulness-based therapy is a type of psychotherapy that will be provided in a group format for 12 weeks.

Group II: Treatment as UsualActive Control1 Intervention

Treatment as usually provided including pharmacotherapy, psychotherapy, and case management as indicated.