Cognitive Behavioral Therapy for Paranoia in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from Baseline in Persecution Severity at week 16 and at week 42.
研究概览
简要总结
The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.
详细描述
Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) is a manualized intervention that combines group and individual modalities to reduce paranoia-biased information-processing and social avoidance, and to increase insight and reality testing capacity.
This is a randomized controlled clinical trial. Twenty four adults ages 18-65 with the primary DSM-IV Schizophrenia and Schizoaffective disorder and drug-refractory persecutory delusions will be recruited from outpatient clinics in New York City Metropolitan area. Participants will be randomly assigned to either experimental or control group. The experimental group will receive PFCBT in addition to standard care and the control group will receive standard care alone. PFCBT will include participation in one group session and one individual therapy session weekly over the 15 weeks. The preliminary efficacy of the intervention will be evaluated using standardized measures by blind evaluators conducted at baseline, post-treatment, and at 6-months post-termination follow-up.
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
- 否
入选标准
- •Age 18 to 65 years
- •Met DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder, confirmed by the Clinical Structural Diagnostic Interview (SCID, First et al, 1997) -Reported persistent and distressing paranoid delusion(s);
- •A minimum severity score of 4 point Persecution subscale on The Positive and Negative Syndrome Scale (PANSS)
- •Had an adequate trial (6 months or more) and were stabilized on antipsychotic medications (no change in psychiatric medication prescribed in the last month
排除标准
- •Substance misuse or medical disorder identified as the primary cause of delusions
研究组 & 干预措施
Cognitive Behavioral Therapy
This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.
干预措施: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) (Behavioral)
Treatment as Usual
This group receives standard care only.
结局指标
主要结局
Change from Baseline in Persecution Severity at week 16 and at week 42.
时间窗: Measured at baseline, at week 16, and at week 42.
Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS).
次要结局
- Change from Baseline in a Tendency to Jump to Conclusions at week 16.(Measured at baseline and at week 16.)
- Change from Baseline in Cognitive Insight at week 16.(Measured at baseline and at week 16.)
- Change from Baseline in Dimensions of Paranoid Delusions(Measured at baseline, at week 16 and at week 42.)
- Change from Baseline in Attributional Style at week 16.(Measured at baseline and at week 16.)