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临床试验/NCT03316664
NCT03316664已完成不适用

Assessment of Efficacy of a Psychological Therapy in Inpatients With a Schizophrenic Psychosis

Psychiatric University Hospital, Zurich2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
2
主要终点
Change from Baseline Symptomatology at 12 Months.

研究概览

简要总结

This randomised three-arm study aims to evaluate the efficacy and feasibility of a cognitive behavioral therapy (INT-Integrated Neurocognitive Therapy for Schizophrenia Patients) in the treatment of schizophrenia patients in an inpatient setting. The intervention will be compared with an active comparator (IPT- Integrated Psychological Therapy) and a control condition. Overall the study will include 90 patients (30 in each arm). Each patient will receive at least 16 sessions of the respective treatment. Baseline and follow up assessments up to 12 months after the intervention will investigate the stability of treatment.

详细描述

Psychotic disorders, and particularly schizophrenia, are severe psychiatric disorders, characterized by psychotic symptoms (mainly hallucinations and delusions), disorganized speech, thought and behavior, and negative symptoms like blunted affect. People who have schizophrenia are chronically impaired. Schizophrenia is one of the first causes of disability worldwide with enormous direct and indirect costs.

The introduction of antipsychotics revolutionized the treatment and care of schizophrenia patients; remaining the cornerstone of schizophrenia treatment. Although new antipsychotics were introduced, they share the same mechanism of action (dopamine D2 antagonism). To date, nearly one-third to half of the patients still do not or respond poorly to antipsychotic treatment; furthermore, some core symptoms of the disorder are not fully addressed by this type of medication.

Parallel to pharmacological treatments, there has been a steady research in psychological interventions for schizophrenia. Current interventions had a more biologic understanding of the disorder and adopted a diathesis-stress model to explain symptoms and course, incorporating adaptation and adjustment through learned and practiced coping strategies. There are many psychological treatments for schizophrenia, although all are considered roughly equivalent, empirical data shows slight differences in efficacy; in particular, Cognitive Behavioural Therapy (CBT) yields small to medium sized effects in addition to psychopharmacological treatment.

There are several available manualized psychological group interventions for patients with a schizophrenic psychosis. One the is the "Integrated Psychological Therapy for Schizophrenia Patients (IPT)", it was developed and introduced into clinical practice almost 30 years ago. It combines neurocognitive and social cognitive interventions with social skills and problem- solving approaches, it has been extensively evaluated by several independent groups, in inpatient and outpatient settings as well, showing an overall improvement in participants.

During the last decade, the cognitive section of IPT was further developed, with the "Integrated Neurocognitive Therapy for schizophrenia patients (INT)" was the final result of this process, with the peculiarity that it was designed to fit the needs of outpatients. While IPT focuses predominantly on the domains of speed of processing, attention, reasoning, and problem-solving as well as on emotion and social perception; INT in contrast targets all 11 neuro- and social-cognitive MATRICS-domains. Furthermore, INT uses computerized neurocognitive exercises for restitution. Initial trials seem to confirm INT as a feasible and efficient group therapy approach with the potential to improve functional outcome in schizophrenia outpatients

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
Double (Investigator, 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

  • Participants are competent to give informed consent.
  • Diagnosis of Schizophrenia or Schizoaffective Disorder (ICD-10).
  • Participants are between 18 and 65 years of age.
  • Fulfillment of regular compulsory education.
  • German language proficiency as a native speaker or level B1

排除标准

  • Unwilling or unable to comply with study instructions.
  • Low Intelligence as stated by failure to accomplish regular compulsory education.
  • Currently in another psychotherapeutic treatment, either in individual or group sessions.
  • Current consumption of Alcohol or illicit Drugs.

结局指标

主要结局

Change from Baseline Symptomatology at 12 Months.

时间窗: Baseline, 2 Weeks, 10 Weeks, 6 Months, and 12 Months.

The "Positive and Negative Syndrome Scale" (PANSS) was designed to measure the severity of psychopathology in adult patients with a psychotic disorder, mainly schizophrenia and schizoaffective disorder.

次要结局

  • Change from Baseline Symptomatology at 12 Months.(Baseline, 2 Weeks, 10 Weeks, 6 Months, and 12 Months.)

研究者

发起方
Psychiatric University Hospital, Zurich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan T. Egger

MD

Psychiatric University Hospital, Zurich

研究点 (2)

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