NCT02170051已完成不适用
Improving Negative Symptoms of Psychosis In Real-world Environments
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
- 64
- 试验地点
- 1
- 主要终点
- Clinical Assessment Interview for Negative Symptoms (CAINS)
研究概览
简要总结
This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention better improves symptoms and functioning in people with schizophrenia.
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
- •MUST BE A RESIDENT OF BROADWAY HOME, SAN DIEGO, OR A SERVICE USER OF THE MEETING PLACE, ARETA CROWELL, OR PROJECT ENABLE.
- •Voluntary informed consent to participate
- •Age 18 to 65
- •DSM-IV diagnosis of schizophrenia or schizoaffective disorder based on MINI/SCID
- •Moderate-to-severe negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS total score >19)
- •≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual)
- •Stable on medications; no changes within 3 months prior to enrollment
排除标准
- •Prior CBT, SST, or CCT in the past 5 years
- •Severe positive symptoms on the Positive and Negative Syndrome Scale (PANSS Delusions, Disorganization, Hallucinations, or Suspiciousness >5)
- •Severe depression on the Calgary Depression Scale for Schizophrenia (CDSS >8)
- •Ocular damage/disease/surgery/medications that affect pupil dilation
- •DSM-IV alcohol or substance dependence diagnosis in past 6 months based on the MINI or SCID
- •Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness) .
研究组 & 干预措施
CBSST-CCT
Experimental
Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
干预措施: CBSST-CCT (Behavioral)
Goal-focused supportive contact
Active Comparator
Goal-focused supportive contact
干预措施: Goal focused supportive contact (Behavioral)
结局指标
主要结局
Clinical Assessment Interview for Negative Symptoms (CAINS)
时间窗: baseline, 12.5 weeks
Change in negative symptom severity at 12.5 weeks. Scores range from 0-52; higher values indicate greater severity.
次要结局
- Social Skills Performance Assessment (SSPA)(baseline, 12.5 weeks)
- MATRICS Consensus Cognitive Battery (MCCB)(baseline, 12.5 weeks)
- UCSD Performance-based Skills Assessment-Brief (UPSA-B)(baseline, 12.5 weeks)
- Specific Levels of Functioning Scale (SLOF)(baseline, 12.5 weeks)
- Independent Living Skills Survey (ILSS)(baseline, 12.5 weeks)
- Defeatist Performance Attitudes Scale (DPAS)(baseline, 12.5 weeks)
- Scale for the Assessment of Negative Symptoms (SANS)(baseline, 12.5 weeks)
研究者
Elizabeth Twamley
Professor of Psychiatry
University of California, San Diego
研究点 (1)
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