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
- 尚未招募
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Independent Living Skills Survey
研究概览
简要总结
This randomized controlled clinical trial will test a blended intervention that combines Executive Function Training with Cognitive-Behavioral Skills Training (E-CBSST). E-CBSST will be delivered to adults with late-life schizophrenia to determine if it increases Cognitive Behavioral Social Skills Training skills learning more than a supportive contact control condition and leads to improved 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 tested a blended intervention that combines Executive Function Training (EFT) with Cognitive-Behavioral Skills Training (E-CBSST) and determined its efficacy for improving Cognitive Behavioral Social Skills Training (CBSST) learning and 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, group-delivered intervention that is repeated to practice the skills for a total of 36 sessions. In an open trial, 54 participants with schizophrenia or schizoaffective disorder age 60 or older were enrolled to receive E-CBSST for 20 weeks. E-CBSST included an initial 2-week course of EFT that included 3 sessions per week of computerized exercises and strategy monitoring using a worksheet and assistance from a therapist. Participants then completed 2 cycles of E-CBSST with 18 sessions each cycle, delivered twice a week, during which participants received brief EFT at the start of CBSST group sessions. Results from this open trial showed that E-CBSST was feasible with acceptable retention and increased CBSST skills learning.
The current study will compare E-CBSST to a control condition combining supportive contact with EFT (E-SC) in a randomized clinical trial. The study aims include confirming target engagement by showing that E-CBSST enhances CBSST skills learning to a greater extent than E-SC and to determine whether functioning improves significantly in E-CBSST and to a greater extent than E-SC. The same 2-cycle dose of E-CBSST from the open trial will be used and E-SC will deliver the same number of EFT and supportive contact sessions. Outcome assessments will be administered at baseline, after the Executive Function Training course (Week 3), after the first cycle of E-CBSST (Week 13; mid-trial), after the end of the second cycle (Week 23; end-trial), and following a 9-month post-treatment follow-up period.
E-CBSST could become an evidence-based intervention that enhances and not only maintains function and, in turn, reduces personal and societal burden. If successful, the next logical step would be a confirmatory effectiveness trial in a larger sample.
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
- 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.
研究组 & 干预措施
E-CBSST
E-CBSST is the experimental arm in this study.
干预措施: E-CBSST (Behavioral)
E-SC
E-SC is the comparator condition in this study.
干预措施: E-SC (Behavioral)
结局指标
主要结局
Independent Living Skills Survey
时间窗: Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
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 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months)
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
- Executive Interview(Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months))
- Positive and Negative Syndrome Scale(Baseline, End of Executive Function Training (Week 3), Mid-Trial (Week 13), End-Trial (Week 23), and Follow-Up (9 months))
研究者
Eric Granholm
Professor
University of California, San Diego