Mindfulness-Based Therapy for Serious Mental Illness

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Butler Hospital
Study ID
NCT06880796
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness-based therapy — BEHAVIORAL
    Mindfulness-based therapy provided in a group format.
  • Treatment as Usual (TAU) — BEHAVIORAL
    Treatment as usually provided.

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
Nov 2025
Primary completion
Apr 1, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness-based therapy
    Mindfulness-based therapy is a type of psychotherapy that will be provided in a group format for 12 weeks.
  • Active Comparator: Treatment as Usual
    Treatment as usually provided including pharmacotherapy, psychotherapy, and case management as indicated.

Primary Outcome Measure

Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Butler HospitalProvidenceRhode Island02906-

Find similar trials in Providence, RI

By condition
Bipolar disorderDepressionSchizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Butler Hospital· Providence, RI

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