CClinicalTrials.gg
Enrolling by invitationNCT06880796MBTUpdated Feb 9, 2026

Mindfulness-Based Therapy for Serious Mental Illness

An interventional study of Mindfulness-based therapy and Treatment as Usual (TAU) in Serious Mental Illness, Schizophrenia and Major Depressive Disorder, sponsored by Butler Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Serious Mental Illness
  • Schizophrenia
  • Major Depressive Disorder
  • Bipolar Disorder
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Not clinically stable enough to participate in treatment.
  • Established weekly mindfulness practice
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • 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

  • Active comparator
    Treatment as Usual

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

    Behavioral: Treatment as Usual (TAU)

Interventions

  • BehavioralMindfulness-based therapy

    Mindfulness-based therapy provided in a group format.

  • BehavioralTreatment as Usual (TAU)

    Treatment as usually provided.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 weeks

Secondary outcomes

  1. 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.

    Time frame: 24 weeks

06

Study locations

1 site
  • Butler Hospital
    Providence, Rhode Island 02906, United States
07

References and documents

Individual participant data

Plan to share: Yes — Deidentified data will be uploaded to the NIMH Data Archive.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06880796
Lead sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Mar 18, 2025
Start date
Nov 25, 2025
Primary completion
Apr 1, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 9, 2026

Study contacts

Brandon Gaudiano, PhD
principal investigator · Butler Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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