Mindfulness-Based Therapy for Serious Mental Illness

NCT06880796 | Enrolling By Invitation DMC

• 2 other identifiers: 2412-001R01MH136540
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  24 weeks

Secondary Outcomes (1)

• WHO Quality of Life-BREF (WHOQOL-BREF)

  24 weeks

Study Arms (2)

Mindfulness-based therapy

EXPERIMENTAL

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

Behavioral: Mindfulness-based therapy

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual (TAU)

Interventions

Mindfulness-based therapy BEHAVIORAL

Mindfulness-based therapy provided in a group format.

Mindfulness-based therapy

Treatment as Usual (TAU) BEHAVIORAL

Treatment as usually provided.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major; Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders

Study Officials

• Brandon Gaudiano, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)