Mindfulness-Based Therapy for Serious Mental Illness

Last updated: March 26, 2025
Sponsor: Butler Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Tourette's Syndrome

Depression

Psychosis

Treatment

Mindfulness-based therapy

Treatment as Usual (TAU)

Clinical Study ID

NCT06880796
2412-001
R01MH136540
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Currently receiving treatment in a community mental health center

  • Diagnosed with schizophrenia-spectrum disorder or major mood disorder based onclinical interview

  • Age 18 years or older

  • Ability to speak and read English

Exclusion

Exclusion Criteria:

  • Not clinically stable enough to participate in treatment.

  • Established weekly mindfulness practice

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Mindfulness-based therapy
Phase:
Study Start date:
December 01, 2025
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

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