跳至主要内容
临床试验/NCT06880796
NCT06880796Enrolling By Invitation不适用

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

Butler Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
160
试验地点
1
主要终点
Brief Psychiatric Rating Scale (BPRS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Mindfulness-based therapy

Experimental

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

干预措施: Mindfulness-based therapy (Behavioral)

Treatment as Usual

Active Comparator

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

干预措施: Treatment as Usual (TAU) (Behavioral)

结局指标

主要结局

Brief Psychiatric Rating Scale (BPRS)

时间窗: 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.

次要结局

  • WHO Quality of Life-BREF (WHOQOL-BREF)(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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