Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.
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
- 否
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
Rikke Jørgensen
MSN ResearchNurse, PhD.Student
University of Aarhus
