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Enrolling by Invitation

NCT Number: NCT06880796

Mindfulness-Based Therapy for Serious Mental Illness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Therapy

Behavioral

Mindfulness-based therapy provided in a group format.

Treatment as Usual (TAU)

Behavioral

Treatment as usually provided.

Primary outcomes

  1. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. WHO Quality of Life-BREF (WHOQOL-BREF)

    Time frame: 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: MBT

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 18, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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