Mindfulness-Based Therapy for Serious Mental Illness

NCT ID: NCT06880796

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-based therapy

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

Group Type: EXPERIMENTAL

Mindfulness-based therapy

Intervention Type: BEHAVIORAL

Mindfulness-based therapy provided in a group format.

Treatment as Usual

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

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Treatment as usually provided.

Interventions

Mindfulness-based therapy

Mindfulness-based therapy provided in a group format.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

Treatment as usually provided.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brandon Gaudiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Central Contacts

Rita Rossi, MA

Role: CONTACT

rrossi@butler.org

401-455-6303

Toni Amaral

Role: CONTACT

tamaral@butler.org

401-455-6377

Facility Contacts

Cheryl Cordeiro

Role: primary

ccordeiro@butler.org

401-455-6654 ext. 26654

Other Identifiers

R01MH136540

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2412-001

Identifier Type: -

Identifier Source: org_study_id