Psychosis in Schizophrenia: Mechanisms of Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Scale for the Assessment of Positive Symptoms (SAPS)
研究概览
简要总结
This study examines the impact of Cognitive-Behavior Therapy (CBT) on symptoms, physiological arousal, stressors, and the ways to deal with them in individuals with schizophrenia and related disorders. The primary aim of this study is to investigate the role cognitive coping strategies play in mediating the link between stress, physiological arousal, and psychotic symptoms in individuals with schizophrenia during recovery from psychosis.
详细描述
This study examines the mechanisms of recovery from psychosis. Specifically, the study aims to evaluate the putative impact of enhancing cognitive coping strategies via Cognitive-Behavior Therapy for psychosis (CBTp) on subjective stress, autonomic regulation (physiological arousal), and psychotic symptoms in individuals with schizophrenia and related disorders. As part of the study, participants will be randomized to receive up to 26 weekly sessions of CBTp (over 30 weeks) or "treatment as usual". Research evaluations will completed at baseline, and after 10, 20 and 30 weeks. The study outcome measures include psychotic symptoms as measured by clinical interviews, along with ambulatory measures of autonomic regulation and self-reports of psychotic experiences during daily functioning using mobile devices (i.e., Palm computers).
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between ages 18-
- •Have capacity to give informed consent.
- •English speaking.
- •Have a DSM-IV diagnosis of schizophrenia, or schizoaffective disorder, or schizophreniform disorder.
- •Presence of active psychosis as indexed by ratings ≥3 on any hallucinations and delusions items of the Scale for Assessment of Positive Symptoms (SAPS).
排除标准
- •Lacks capacity to give informed consent.
- •Diagnosis of mental retardation (IQ < 80).
- •Have history of neurological disorders or medical conditions known to seriously affect the brain.
- •Have history of cardiac conditions or hypertension; current use of anti-cholinergic, beta-blockers, anti-histamine, or anti-hypertensive medication; abnormalities on ECG.
- •Have used street drugs within the past 4 weeks.
结局指标
主要结局
Scale for the Assessment of Positive Symptoms (SAPS)
时间窗: At Baseline and after 10, 20 and 30 weeks
次要结局
- Momentary ambulatory measures of heart rate and breathing(At Baseline and after 30 weeks)
- Momentary self-report ratings of stress and coping strategies using a Palm computer(at Baseline and after 30 weeks)
- Momentary self-report ratings of psychotic symptoms using a Palm computer(At Baseline and after 30 weeks)