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临床试验/NCT00601224
NCT00601224已完成1 期

Social Cognition and Interaction Training for Schizophrenia

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
66
试验地点
2
主要终点
Face Emotion Identification Task (FEIT)

研究概览

简要总结

This study will determine the effectiveness of social cognition and interaction training, a manual-based group therapy program, in helping people with schizophrenia improve their social cognition and social functioning.

详细描述

Schizophrenia is a serious mental condition that affects approximately 1.1% of adults in the United States. People with schizophrenia experience reality perception impairments, which most commonly manifest as hallucinations, extreme paranoia, social withdrawal, and disordered thinking. Deficits in social functioning are a core feature of schizophrenia. In an effort to improve social functioning, there has been growing interest in identifying factors that underlie psychosocial impairments. One such identified factor has been neurocognition, but treatments that target solely cognitive processes do not always help overall social functioning. Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of SCIT versus treatment as usual (TAU) in helping people with schizophrenia improve their social cognition and social functioning.

Participation in this single-blind study will last 11 months. All potential participants will undergo initial screening, involving the completion of a few brief tasks testing social functioning. Eligible participants will then be randomly assigned to receive SCIT plus TAU or TAU alone. Participants assigned to receive SCIT will attend twenty 1-hour weekly group sessions over 5 months. During these sessions, participants will learn ways to manage emotions, work through problems, and integrate into social situations. Participants assigned to TAU alone will meet with their case managers and healthcare provider on an as-needed basis. All participants will undergo assessments of social cognition, social functioning, and psychotic symptoms prior to treatment, immediately post-treatment, and 6 months after treatment. Each assessment will last 3 hours and will include interviews, questionnaires, and a variety of tasks testing social skills. Researchers will also contact a family member or significant other about the participant's social functioning at the same three assessment times noted above.

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

入选标准

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder, based on the Structured Interview of DSM-IV patient version (SCID-P)

排除标准

  • Meets current criteria for substance dependence, based on the SCID-P
  • Meets criteria for metal retardation (e.g., has an IQ of less than 80)
  • History of brain injuries
  • Difficulties interacting with others, based on ratings on items from the Social Functioning Scale that tap interactional skills

结局指标

主要结局

Face Emotion Identification Task (FEIT)

时间窗: Measured at baseline, post-treatment, and 6-month follow-up

Face Emotion Discrimination Task (FEDT)

时间窗: Measured at baseline, post-treatment, and 6-month follow-up

The Hinting Task

时间窗: Measured at baseline, post-treatment, and 6-month follow-up

The Awareness of Social Inference Test (TASIT)

时间窗: Measured at baseline, post-treatment, and 6-month follow-up

Ambiguous Intentions Hostility Questionnaire(AIHQ)

时间窗: Measured at baseline, post-treatment, and 6-month follow-up

次要结局

  • Social Skills Performance Assessment (SSPA)(Measured at baseline, post-treatment, and 6-month follow-up)
  • Quality of Life Scale (QLS)(Measured at baseline, post-treatment, and 6-month follow-up)
  • Positive and Negative Syndrome Scale (PANSS)(Measured at baseline, post-treatment, and 6-month follow-up)
  • "Beads in the Jar" Task(Measured at baseline, post-treatment, and 6-month follow-up)
  • Schizophrenia Cognition Rating Scale (SCoRS)(Measured at baseline, post-treatment, and 6-month follow-up)
  • Overt Social Cognition: A Rating Scale (OSCARS)(Measured at baseline, post-treatment, and 6-month follow-up)
  • Lecomte Self-Esteem Scale(Measured at baseline, post-treatment, and 6-month follow-up)
  • Number of Hospital Admissions(Measured at baseline, post-treatment, and 6-month follow-up)

研究者

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

David Penn, PhD

Professor of Psychology

University of North Carolina, Chapel Hill

研究点 (2)

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