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临床试验/NCT02421237
NCT02421237已完成不适用

Randomized Controlled Trial of Treatment for Internalized Stigma in Schizophrenia

John Jay College of Criminal Justice, City University of New York1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
Change in Internalized Stigma of Mental Illness Scale

研究概览

简要总结

The purpose of the present study is to build upon the investigators' previous exploratory intervention development study by conducting an adequately-powered, randomized controlled trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with schizophrenia-spectrum disorders.

详细描述

Internalized (or self) stigma develops when people with mental illness become aware of stigmatizing attitudes held by many in society about mental illness (e.g., dangerousness, incompetence, inability to work), perceive these attitudes as being legitimate, and apply them to themselves. There is substantial evidence that internalized stigma is strongly negatively linked to both the objective (e.g., social functioning) and subjective (e.g., self-esteem and well-being) components of recovery for persons with schizophrenia, and that these effects operate independent of symptom-related disability. Nevertheless, few efforts have been made to develop treatment to address this issue. Previously, the investigators were funded to develop a group-based intervention (R34MH082161) combining cognitive-behavioral therapy and narrative psychotherapy to address internalized stigma among people with severe mental illness. The purpose of the present study is to build upon the investigators' previous exploratory intervention development study by conducting an adequately-powered, randomized controlled trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with schizophrenia-spectrum disorders. The investigators will screen 500 persons at two sites (Newark, New Jersey and Indianapolis, IN) for evidence of moderate or elevated internalized stigma. They will conduct a randomized study of NECT versus supportive group therapy in a sample of 175 individuals meeting Structured Clinical Interview criteria for schizophrenia-spectrum disorders. Randomization will be stratified by baseline self-stigma severity (moderate or elevated), to ensure roughly equal numbers of participants for each stratum. Participants will complete baseline, post-treatment, 3-month post treatment and 6-month post treatment assessments of internalized stigma, psychiatric symptoms, insight, self-esteem, hopelessness, coping, narrative coherence and social functioning. The specific aims of the project are: 1) Conduct a randomized study of the effectiveness of NECT, comparing outcomes for 175 persons with schizophrenia-spectrum disorder randomly assigned to NECT or supportive group therapy, 2) Examine the mediating impact of changes in narrative coherence and in the use of problem-centered coping strategies on outcomes for persons assigned to the NECT treatment. The intervention can have important implications for enhancing usual care services to reduce disability for people with schizophrenia, and therefore has potentially important implications for improving the public health.

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
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Schizophrenia-spectrum disorder (schizophrenia or schizoaffective)
  • Elevated internalized stigma

排除标准

  • Current substance dependence
  • Inability to speak English
  • Inability to provide informed consent

研究组 & 干预措施

Experimental condition

Experimental

Narrative enhancement and cognitive therapy (NECT) groups. Structured psychoeducational and skills-training groups focused on self-stigma and its impact on people with schizophrenia

干预措施: Narrative Enhancement and Cognitive Therapy (Behavioral)

Control condition

Active Comparator

Supportive group therapy groups. Unstructured supportive groups not focused on self-stigma.

干预措施: Supportive Group Therapy (Behavioral)

结局指标

主要结局

Change in Internalized Stigma of Mental Illness Scale

时间窗: Up to 11 months post baseline

Change in Beck Hopelessness Scale

时间窗: Up to 11 months post baseline

Change in Rosenberg Self-Esteem Scale

时间窗: Up to 11 months post baseline

次要结局

  • Change in Heinrichs Quality of Life Scale(Up to 11 months post baseline)

研究者

发起方
John Jay College of Criminal Justice, City University of New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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