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临床试验/NCT00356317
NCT00356317已完成2 期

A Culturally Based Family Therapy for Schizophrenia

University of Miami2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
400
试验地点
2
主要终点
Schizophrenia symptom severity

研究概览

简要总结

This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.

详细描述

Schizophrenia is a disabling mental disorder that affects approximately 1% of the population worldwide. People with schizophrenia frequently experience hallucinations, delusions, disordered thinking, movement disorders, emotional numbness, social withdrawal, and cognitive deficits. These symptoms can hinder a person's ability to perform everyday functions, such as hold a job and maintain normal social relationships. When combined with medication, family-oriented therapy interventions have been beneficial for people with schizophrenia. There are few programs, however, that are tailored to the needs of minorities. With the rising number of minority populations in the U.S., it is important to develop psychotherapy interventions that are designed specifically for these groups. This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.

Participants in this 12-month, open label study will first attend a 2-hour screening visit, at which information will be gathered regarding coping styles, spirituality, and expressed emotion. Participants will then be randomly assigned to receive either culturally based therapy or treatment as usual. Although the culturally based therapy will be tailored to the needs and values of Hispanics, people who are not Hispanic will not be excluded. The culturally based therapy will entail 15 weekly therapy sessions, which will focus on family unity, psychoeducation, spirituality, communication skills, and problem-solving. The group receiving treatment as usual will attend 3 weekly psychoeducation sessions that will focus on informing participants about schizophrenia. Outcomes for both groups will be assessed upon completion of treatment and at follow-up visits at Months 6 and 12.

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
None

入排标准

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

入选标准

  • For participants with schizophrenia or schizoaffective disorder:
  • Diagnosis of schizophrenia or schizoaffective disorder
  • Currently taking medication
  • 18 or older
  • For all participants:
  • Two or more family members, including patient, are available for participation (therapy can be conducted if patient is not available, as long as two other family members are interested in participating)
  • Family members must be at least 13 years old

排除标准

  • 未提供

结局指标

主要结局

Schizophrenia symptom severity

时间窗: Measured immediately post-treatment and at Months 6 and 12

次要结局

  • Cultural Identity(Measured immediately post-treatment and at Months 6 and 12)
  • Coping styles(Measured immediately post-treatment and at Months 6 and 12)
  • Symptoms of depression, anxiety, and stress(Measured immediately post-treatment and at Months 6 and 12)
  • Family functioning(Measured immediately post-treatment and at Months 6 and 12)
  • Religiosity/Spirituality(Measured immediately post-treatment and at Months 6 and 12)
  • Alcohol and Drug Use(Measured immediately post-treatment and at Months 6 and 12)
  • Knowledge and knowledge about schizophrenia(Measured immediately post-treatment and at Months 6 and 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Weisman

Associate Professor

University of Miami

研究点 (2)

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