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临床试验/NCT03261557
NCT03261557已完成不适用

Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.

Hospital Clinic of Barcelona3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年2月22日最近更新:
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
30
试验地点
3
主要终点
Psychosocial functioning

研究概览

简要总结

Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended psychological interventions to improve symptomatology and functional recovery in psychosis. In addition, CBT may reduce hyperactivation of the brain structures responsible for the stress response. In patients with early onset psychotic disorder (EOP) there are not any previous controlled study that has analyzed the efficacy of this type of intervention.

The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional improvement after the treatment in patients with EOP. The study will also examine the potential effect of the intervention on neurobiological stress markers.

详细描述

Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a worse clinical and psychosocial evolution than in the adult form of the illness. In the case of patients with EOP, international and national clinical guidelines recommend the combination of pharmacological treatment with CBT. However there are not any previous controlled study that has analyzed the efficacy of this type of psychological intervention.

A controlled randomized study will be carry out of CBT + SST intervention compared to a control intervention of the same duration, format and contact with a therapist. The sample will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to be in the early phase of the disease (first 5 years after the onset) and in non-acute treatment. All participants will be evaluated before and after the intervention with clinical scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age, puberal stage and sex will be also recruited and evaluated only at baseline point. The evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 20.

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
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with a diagnosis of non-affective psychotic disorder diagnosed between age of 9 and 18 (Schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified according to DSM-V criteria).
  • Critical period after the first psychotic episode (which covers the first 5 years) and in non-acute treatment

排除标准

  • Toxic dependence comorbid disorder
  • Presence of Neurological disorder.

研究组 & 干预措施

CBT + SST

Experimental

The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents.

干预措施: CBT + SST (Behavioral)

Psychoeducation, habits and healthy lifestyle

Active Comparator

The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle.

干预措施: Psychoeducation, habits and healthy lifestyle (Behavioral)

结局指标

主要结局

Psychosocial functioning

时间窗: 15 weeks

Change from baseline in social functioning questionnaires

Clinical symptoms

时间窗: 15 weeks

Change from baseline in Clinical scales

次要结局

  • Subjective stress(15 weeks)
  • Biological stress markers(15 weeks)

研究者

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

Olga Puig

Clinical psychologist

Hospital Clinic of Barcelona

研究点 (3)

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