Mobile-Assisted Cognitive Behavior Therapy for Negative Symptoms in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Defeatist performance beliefs (target mechanism)
研究概览
简要总结
This clinical trial will test a combined group therapy plus mobile cognitive behavioral therapy intervention targeting defeatist attitudes in consumers with schizophrenia in order to change motivational negative symptoms linked to defeatist attitudes.
详细描述
The primary purpose of this project is to test whether a psychosocial intervention, Cognitive Behavioral Social Skills Training (CBSST) combined with a smartphone-based cognitive-behavioral therapy for negative symptoms called, Mobile-assisted Cognitive Behavioral Therapy for Negative Symptoms (mCBTn) can reduce defeatist performance attitudes in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms.The project will also identify the optimal dose to engage the defeatist attitude target. Pupillary responses, an objective psychophysiological biomarker of effort, will be recorded during a cognitive task as a secondary outcome to determine its potential as an end point in clinical trials of motivation and effort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DSM-5 diagnosis of schizophrenia or schizoaffective disorder.
- •Meets prospective criteria for persistent moderate-to-severe experiential negative symptoms in at least two of the three CAINS Motivation and Pleasure domains (mean of 2 -moderate- or greater for items averaged within the Social, Work or Recreational domains) at the beginning and end of a 2-week evaluation phase.
- •Moderate-to-severe defeatist attitudes (DPAS > 50).
- •≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed for reading treatment manual consumer workbook).
- •Clinically stable and stable on current medications (no changes within 3 months prior to enrollment and meeting all inclusion/exclusion criteria during longitudinal baseline evaluation at both week -2 and 0).
排除标准
- •Prior CBT in the past 2 years.
- •Greater than moderate PANSS positive symptoms (P1-Delusions, P2- Disorganization, P3-Hallucinations, or P6-Suspiciousness - any item >5).
- •Severe depression on the Calgary Depression Scale for Schizophrenia (CDS >8).
- •Extrapyramidal symptoms (Simpson-Angus Scale >7).
- •Ocular damage, disease, surgery or medications that affect pupil dilation.
- •DSM-5 alcohol or substance use disorder in past 3 months.
- •Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness).
- •Unable to adequately see or manually manipulate the mobile device.
结局指标
主要结局
Defeatist performance beliefs (target mechanism)
时间窗: Assess change from baseline in defeatist performance beliefs at weeks 12, 18 and 24.
Measure reduction of defeatist performance beliefs severity using the Defeatist Performance Attitude Scale.
次要结局
- Pupillary responses as effort biomarker(Assess change from baseline in pupil dilation at week 12, 18 and 24.)
- Clinical Assessment Interview for Negative Symptoms (CAINS)(Assess change from baseline in negative symptoms at week 12, 18 and 24.)
研究者
Eric Granholm
Professor In Residence
University of California, San Diego