Mobile-assisted Cognitive Behavioral Therapy for Negative Symptoms in Schizophrenia: An RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Defeatist performance beliefs (target mechanism) using the Defeatist Performance Attitude Scale
研究概览
简要总结
This randomized controlled clinical trial will test a combined group contact plus mobile CBT-informed skills training intervention targeting defeatist attitudes in consumers with schizophrenia in comparison to a supportive contact control group in order to change motivational negative symptoms linked to defeatist attitudes.
详细描述
The primary purpose of this project is to determine if mCBTn at the optimal dose from the R61 produces greater reduction in severity of defeatist attitudes than a supportive contact control group in consumers with schizophrenia spectrum disorders with persistent moderate-to-severe experiential negative symptoms. A second aim is to determine whether reduction in defeatist attitudes mediates improvement in experiential negative symptoms and psychosocial functioning in mCBTn. The third aim is to determine whether mCBTn increases pupil dilation and whether changes in pupil dilation (an objective psychophysiological biomarker of effort) are associated with changes in defeatist attitudes and negative symptoms. The final aim is to explore predictors of response to mCBTn, including device use and group session adherence, demographics, neurocognitive impairment, and negative and other symptom severity at baseline.
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 60 Years（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/
排除标准
- •during longitudinal baseline evaluation at both week -2 and 0).
- •Exclusion Criteria:
- •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.
- •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 skills training (e.g., hospitalized; severe medical illness).
- •Unable to adequately see or manually manipulate the mobile device.
研究组 & 干预措施
Mobile-assisted CBT-informed Skills Training
Psychosocial intervention combining in-person and smartphone-based CBT-informed skills training for experiential negative symptoms in schizophrenia, called Mobile-assisted Cognitive-Behavioral Therapy for Negative symptoms (mCBTn).
干预措施: Mobile-assisted CBT-informed Skills Training (Behavioral)
Supportive Contact
An active group leader- and device-contact control group.
干预措施: Supportive Contact (Behavioral)
结局指标
主要结局
Defeatist performance beliefs (target mechanism) using the Defeatist Performance Attitude Scale
时间窗: Assess change from baseline in defeatist performance beliefs at weeks 9, 18, and 42.
Measure changes in defeatist performance beliefs severity using the Defeatist Performance Attitude Scale (DPAS). The DPAS is a 5-minute, 15-item self-report subscale derived from factor analysis of the commonly-used 40-item Dysfunctional Attitude Scale, which measures the tendency to overgeneralize from past failure experiences and form defeatist beliefs about the ability to perform future goal-directed tasks. Items are rated on a 1-7 Likert scale. A total score is reported with a range of 7 - 105 with higher total scores indicating more severe defeatist performance attitudes.
Clinical Assessment Interview for Negative Symptoms (CAINS)
时间窗: Assess change from baseline in negative symptoms at weeks 9, 18, and 42.
Measure changes in motivational negative symptoms on the CAINS. The CAINS is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. Total scores for each factor are computed. The range for the MAP is 0 - 36, and the range for the Expression factor is 0 - 16. Higher scores indicate more severe negative symptoms for both factors.
次要结局
- Pupillary responses as effort biomarker(Assess change from baseline in pupil dilation at weeks 9, 18, and 42.)
- Birchwood Social Functioning Scale (SFS)(Assess change from baseline in functioning at weeks 9, 18, and 42.)
研究者
Eric Granholm
Professor In Residence
University of California, San Diego