跳至主要内容
临床试验/NCT02576613
NCT02576613已完成不适用

Modified Psychodynamic Psychotherapy for Patients With Schizophrenia - a Randomized Controlled Trial

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
psychosocial functioning

研究概览

简要总结

A randomized controlled, prospective, two-armed, mono-centric, assessor-blinded clinical trial will serve to generate preliminary data on the efficacy and safety of modified psychodynamic therapy (MPP-S) in stabilized patients after the first or subsequent episodes of schizophrenia or schizoaffective disorder.

详细描述

Rationale: Compared to the existing evidence for other psychotherapy methods like cognitive-behavioral psychotherapy or family interventions, the scientific basis of psychodynamic psychotherapy for psychoses is weak with respect to randomized-controlled research. Its encouragement by expert opinion and the broad application of this method stands in sharp contrast to the apparent lack of research interest regarding its efficacy and safety and the fact that more people suffering from schizophrenic spectrum disorders will hopefully embark on psychotherapy in the coming years.

The aim of the presented study is therefore on the one hand to explore the efficacy and safety of modified psychodynamic psychotherapy (MPP-S) in a randomized controlled study design. On the other hand, psychodynamic assumptions regarding the treatment of psychotic persons shall be elucidated in an explorative part of the study. For this purpose, a newly developed manual of modified psychodynamic psychotherapy for psychoses will be inaugurated.

Primary objective of the study is to determine whether the administration of MPP-S in addition to standard treatment (=treatment as usual: TAU) will lead to an improvement of psychosocial functioning in outpatients with schizophrenia and schizo-affective disorder compared to standard treatment.

Secondary objectives refer to the question, whether symptom domains and necessity of hospital treatment, as well as interpersonal functioning and subjective recovery might be impacted by MPP-S compared to TAU alone. Moreover, theoretical assumptions about possible psychodynamic mechanisms of action of MPP-S led to exploratory hypotheses, which are to be tested.

Safety and tolerability of the psychodynamic intervention will be evaluated by acquisition of safety data during study visits, but also by continuous monitoring of participants' condition after every treatment session and clinical contact.

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

  • Diagnosis of schizophrenia or schizo-affective disorder according to DSM-IV-TR
  • Age 18-64 years
  • Sufficient German language competence
  • Written informed consent
  • Consent to audio recording of psychotherapy sessions and video-taping of assessment interviews at study visits

排除标准

  • Organic brain disorder
  • Relevant somatic disorder impairing cerebral function
  • Relevant abuse alcohol and illegal drugs as assessed by a current or previous indication for treatment for addiction
  • Inability to understand and comply with the requirements of the study and to give written informed consent
  • CDSS-item for suicidal ideation is marked >/= 2
  • Massive agitation or current endangerment of others

研究组 & 干预措施

standard therapy (TAU)

Experimental

clinical standard treatment, including supportive therapeutic contacts, pharmacotherapy, creative and occupational therapies, psychoeducation, group therapies, excluding structured individual or group psychotherapy

干预措施: TAU (Other)

结局指标

主要结局

psychosocial functioning

时间窗: 36 months

Primary endpoint is the Mini-ICF-APP (=Mini-International Classification of Functioning for limitations of Activities and Participation in Psychological disorders)

次要结局

  • general symptom severity(36 months)
  • psychotic symptom severity(36 months)
  • metacognitive function(36 months)
  • depressive symptom severity(36 months)
  • self-rated ability to solve interpersonal problems(36 months)
  • cognitive and emotional mentalization(12 months)
  • necessity of hospital treatment(36 months)
  • psychic "structure"(36 months)
  • "mentalized affectivity" and emotional awareness(24 months)
  • ability to make subjective sense of psychotic experiences(36 months)
  • Changes in cerebral functional activity, connectivity, structure of social cognitive and default-mode networks from Baseline(24 months)

研究者

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

Christiane Montag MD

Principal Investigator

Charite University, Berlin, Germany

研究点 (2)

Loading locations...

相似试验

Modified Psychodynamic Psychotherapy for Patients... | 临床试验