Optimizing Cognitive Behavioral Social Skills Training With Executive Function Training for Older Adults With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Independent Living Skills Survey
研究概览
简要总结
The purpose of this research study to test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). The aims include determining whether E-CBSST is feasible and increases Cognitive Behavioral Social Skills Training (CBSST) Skills Learning to a level that will lead to a clinically meaningful improvement in functioning.
详细描述
Older adults with schizophrenia are at risk for cognitive and functional decline leading to premature institutionalization. A large and increasing number of older people with schizophrenia will need more effective services. The investigators previously developed Cognitive Behavioral Social Skills Training (CBSST) and established its efficacy for preventing functional decline in people with schizophrenia. CBSST combines Cognitive Behavioral Therapy (CBT), Social Skills Training (SST), and problem-solving intervention modules in an 18-session intervention that is repeated to practice the skills for a total of 36 sessions. The findings suggested that CBSST Skills Learning is an important mechanism of change in functioning in CBSST and that boosting executive function could boost CBSST Skills Learning, which could improve rather than only stabilize functioning. The investigators intend to test a blended intervention that combines CBSST and Executive Functioning Training (E-CBSST). In this open trial, 50 participants with schizophrenia or schizoaffective disorder age 60 or older will be enrolled to receive E-CBSST for 20 weeks. E-CBSST will consist first of a 2-week Executive Function Training (EFT) course that includes 3 sessions per week of computerized exercises and strategy monitoring using a worksheet and assistance from a therapist. Participants will then complete 2 cycles of E-CBSST with 18 sessions each cycle, delivered twice a week, during which participants receive brief EFT at the start of CBSST group sessions. Outcome assessments will be administered at baseline, end of Executive Function Training course (Week 2), after session 18 (mid-trial; end of first cycle) and session 36 (end-trial; end of second cycle).
The aims of the study include determining if E-CBSST is feasible and increases CBSST Skills Learning to a level that will lead to a clinically meaningful improvement in functioning and to identify the minimum number of weeks of the intervention needed to produce this change. E-CBSST could become an evidence-based intervention that enhances and not only maintains function and, in turn, reduces personal and societal burden.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary informed consent to participate;
- •Age 60 years or older;
- •DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on the SCID;
- •Be clinically stable as operationalized by (1) not having been admitted to a psychiatric hospital within the three months prior to assessment, (2) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (3) and ascertained to be clinically and medically stable by one the study investigators;
- •Be willing and able to speak English;
- •Be able to read and converse (with corrected vision or hearing if needed).
排除标准
- •Meets criteria for a cognitive disorder or for a neurological or other medical disorder affecting the ability to participate in Executive Function Training or CBSST;
- •Meets diagnostic criteria for bipolar disorder, current major depressive episode, or substance abuse or dependence within the six months prior to the baseline assessment except for caffeine or nicotine;
- •Received electroconvulsive therapy within six months of the baseline assessment.
结局指标
主要结局
Independent Living Skills Survey
时间窗: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
The Independent Living Skills Survey (ILSS) assesses whether specific functioning behaviors have been performed over the past month in multiple areas: Personal Hygiene, Appearance and Care of Clothing, Care of Personal Possessions (everyday household chores), Food Preparation, Health Maintenance, Money Management, Transportation, and Leisure and Community (including socialization). Each item is rated from 0 (No) to 1 (Yes). Scales are summed to yield a total score. Higher scores represent a higher level of functioning.
Comprehensive Modules Test
时间窗: Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20)
The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
次要结局
- Clinical Assessment Interview for Negative Symptoms(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Defeatest Performance Attitudes Scale(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Social Skills Performance Assessment(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Delis-Kaplan Executive Function System(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Executive Interview(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Geriatric Depression Scale(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Cumulative Illness Rating Scale-Geriatric(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Brief Assessment of Cognition in Schizophrenia(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Positive and Negative Syndrome Scale(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
- Birchwood Social Functioning Scale(Baseline, End of Executive Function Training (Week 2), Mid-Trial (Week 11), End-Trial (Week 20))
研究者
Eric Granholm
Professor
University of California, San Diego