Treating Negative Symptoms of Schizophrenia With a Motive-specific Intervention: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Long-term Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
研究概览
简要总结
The aim of this study is to test a therapeutic intervention to reduce negative symptomatic among schizophrenia patients. Since the intervention can take place within an inpatient stay, it is a short intervention. Three appointments are made with the patients within two weeks. With an adaptation of the Autobiographical Memory Test (AMT) participants will be asked to recall events from the past and to imagine future events. Patients are additionally asked to complete tasks between the sessions. One pre- and one post-measurement of negative symptoms, motives, level of functioning, hope for recovery and other co-variables are part of the study. A follow-up appointment four weeks later is intended to provide information on the longer-term impact.
详细描述
Clinically relevant negative symptoms are present in almost 60% of all patients suffering from schizophrenia. Motivational deficits seem to be one of the main barriers in the process of "functional recovery" among those patients and have been shown to be very treatment resistant. Effects of pharmacological compounds are at best moderate. There are some psychotherapeutic intervention studies that show promise but further controlled trials are needed to clarify the specific treatment effects.
Therefore, patients shall be encouraged to remember memories that stand in an association with specific motives. Motives are conscious and unconscious affect-based needs that are activated by behavior and influence behavior toward specific incentives in specific circumstances. They influence the selection of everyday goals and have influence on the degree of the progress people are making towards these goals. The intervention is based on the assumption that a positive expectation of the future is constituted among others by positive experiences from the past and at the same time increases the motivation for future behaviour. The activation of specific, motive-associated memories from autobiographical memory and their transformation into images of the future by means of imaginative methods could be a possible way of strengthening certain motives and thus increasing motivation for certain behaviour. This is mainly because there is evidence that psychosis patients have difficulties specifically remembering memories, i.e. those that happened on only one day. In addition, there is a diminished ability to create specific images of their personal future.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Male and female inpatients between 18 and 65 years of age
- •ICD-10 diagnosis of psychosis (F2)
- •Clinical relevant negative symptoms
- •Ability to judge with regard to decisions on study participation
- •Fluent in German and able to understand the instructions
排除标准
- •Florid positive psychotic symptoms (measured with PANSS; that is any positive-subscale item score higher than five)
- •Post-schizophrenic depression (ICD: F20.4)
- •Organic schizophrenia-like disorder (ICD: F0.6)
- •Known or suspected non-compliance, drug or alcohol abuse during treatment
- •Cognitive impairments: strongly below average values in cognitive tests
- •Complete stop or restart of taking antipsychotic medication during the study (dose adjustments are not a reason for exclusion)
- •Previous enrolment in the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
结局指标
主要结局
Long-term Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
时间窗: 4 weeks after end of the psychotherapeutic intervention
Another primary outcome criterion is the change of the severity of the negative symptoms in schizophrenia patients who have received the motive-specific intervention compared to the control group patients in a follow-up appointment four weeks after termination of the intervention. Negative symptoms are measured with the Brief Negative Symptom Scale (BNSS) and items are rated on a 7-point-scale (0 = absent, 6 = severe).
Reduction of negative symptoms measured with the Brief Negative Symptom Scale (BNSS)
时间窗: Baseline
The primary outcome criterion is the change and expected reduction of the severity of the negative symptoms in schizophrenia patients before and after the three-week motive-specific intervention. We compare the change of severity between the patients of the intervention group and those in the control group. Negative symptoms are measured with the Brief Negative Symptom Scale (BNSS) and items are rated on a 7-point-scale (0 = absent, 6 = severe).
次要结局
- Correlation between the severity of negative symptoms and explicit motives measured with the Questionnaire for the Zurich Model of Social Motivation(Baseline)
- Correlation between the severity of negative symptoms and implicit motives measured with the Multi Motive Gitter(Baseline)