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Mindfulness-Based Therapy for Serious Mental Illness

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06880796
Acronym
MBT
Enrollment
160
Registered
2025-03-18
Start date
2025-11-25
Completion date
2029-12-31
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serious Mental Illness, Schizophrenia, Major Depressive Disorder, Bipolar Disorder

Brief summary

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.

Interventions

Mindfulness-based therapy provided in a group format.

BEHAVIORALTreatment as Usual (TAU)

Treatment as usually provided.

Sponsors

Butler Hospital
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Brief Psychiatric Rating Scale (BPRS)24 weeksThe 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.

Secondary

MeasureTime frameDescription
WHO Quality of Life-BREF (WHOQOL-BREF)24 weeksThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBrandon Gaudiano, PhD

Butler Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026