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临床试验/NCT01282307
NCT01282307已完成不适用

Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.

University of Aarhus2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
changes in cognitive insight over time

研究概览

简要总结

Background:

Rehospitalisation and discontinued treatment are common among patients with schizophrenia and is often associated with lack of insight into the illness. Improving patients' insight has been attempted through psychoeducation and standard treatment but without any considerable change. A newly developed method, Guided Self-Determination (GSD), originally developed and proved effective in difficult diabetes care has been adjusted to patients with schizophrenia. A qualitative evaluation of GSD has shown a positive influence on patients' insight into the illness.

Aim and hypotheses: The aim of the study is to evaluate the effects of the method GSD in the care of patients with schizophrenia compared to treatment as usual. The following hypotheses will be tested:

The method GSD will improve: Cognitive and clinical insight in patients, various domains of recovery, patients' self-esteem, psychopathology and social functioning.

Material and method:

The study design is a randomised controlled trial. The participants are diagnosed with schizophrenia and schizoaffective disorder, receiving treatment in 3 Assertive Outreach Teams and 3 Psychosis Teams in Region North. Participants complete four self-rating questionnaires, a demographic data sheet, an interview concerning psychopathology and an assessment of social functioning at baseline, and after 3, 6, and 12 month. All assessments will be conducted by the investigator, except for the assessment of social functioning, that will be measures by community nurses. Intervention with the method GSD will also be conducted by the community nurses but under supervision from the investigator. Fifty patients are randomly assigned to immediate receipt of individual training with the method GSD (intervention group) and 50 to a 12-month waiting list for individual training with the method GSD (control group).

Perspectives:

In mental health nursing practice in Denmark there is no tradition for empirical research as the basis of psychiatric nursing - unverified theories or general empirical consensus of good clinical practice are often the foundation of psychiatric nursing. If the method GSD proves effective in the care of patients with schizophrenia, this study contributes to an evidence based nursing intervention, which is ready for further research on implementation in mental health nursing practice.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient's hospital record meeting the criteria for schizophrenia according to ICD-10 F.20.0-9 or schizoaffective disorder according to ICD-10 F.25.0-9
  • Age 18 - 70 years at the time of inclusion
  • Ability to understand, speak and write Danish - assessed by the community nurse
  • Informed written consent
  • receiving treatment in an assertive outreach team or psychosis team in region north in Denmark

排除标准

  • Previous participation with the method GSD
  • Patients who are mentally handicapped or diagnosed with any kind of dementia or an organic brain disease according to their hospital record
  • In need of an interpreter to understand, speak and write Danish
  • Withdrawal of informed consent

结局指标

主要结局

changes in cognitive insight over time

时间窗: baseline, 3,6 and 12 month

Cognitive insight is measured by the selvrating questionnaire Beck Cognitive Insight Scale (BCIS).

次要结局

  • Changes in Clinical insight over time(baseline, 3,6,12 month)
  • changes in various domains of recovery over time(baseline, 3,6,12 month)
  • changes in self-esteem over time(baseline, 3,6,12 month)
  • changes in psychopathology over time(baseline, 3,6,12 month)
  • changes of social function over time(baseline, 3,6,12 month)
  • Therapeutic relationship(12 month)

研究者

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

Rikke Jørgensen

MSN ResearchNurse, PhD.Student

University of Aarhus

研究点 (2)

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