Mindfulness-Based Therapy for Serious Mental Illness (MBT)

Evaluating the Effectiveness of Mindfulness-Based Therapy for SMI Implemented in a Community Mental Health Setting

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder; Serious Mental Illness
• Intervention / Treatment: Behavioral: Mindfulness-based therapy; Behavioral: Treatment as Usual (TAU)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Currently receiving treatment in a community mental health center
• Diagnosed with schizophrenia-spectrum disorder or major mood disorder based on clinical interview
• Age 18 years or older
• Ability to speak and read English

Exclusion Criteria:

• Not clinically stable enough to participate in treatment.
• Established weekly mindfulness practice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based therapy; Mindfulness-based therapy is a type of psychotherapy that will be provided in a group format for 12 weeks.	Behavioral: Mindfulness-based therapy; Mindfulness-based therapy provided in a group format.
Active Comparator: Treatment as Usual; Treatment as usually provided including pharmacotherapy, psychotherapy, and case management as indicated.	Behavioral: Treatment as Usual (TAU); Treatment as usually provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Psychiatric Rating Scale (BPRS)	The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHO Quality of Life-BREF (WHOQOL-BREF)	The WHOQOL-BREF is a 26-item self-report measure of quality of life. Items are rated on a scale from 1 to 5 with total scores ranging from 26 to 130, with higher scores indicating higher quality of life.	24 weeks

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Brandon Gaudiano, PhD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Mood Disorders; Depressive Disorder; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Therapeutics
• Other Study ID Numbers: 2412-001; R01MH136540 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be uploaded to the NIMH Data Archive.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No