Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 378
- 试验地点
- 10
- 主要终点
- Change in Social Adjustment Scale II
研究概览
简要总结
To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.
详细描述
Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.
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
- •age 18 to 65;
- •DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview);
- •estimated IQ of > 70 (established via WTAR).
排除标准
- •the presence of a current organic brain syndrome;
- •intellectual disability (DSM-5);
- •participation in either CET or SST within the prior year.
结局指标
主要结局
Change in Social Adjustment Scale II
时间窗: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning
Change in Social Skills Performance Assessment
时间窗: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning using role played scenarios
Change in Heinrich Quality of Life Scale
时间窗: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning
次要结局
- Change in Picture Sequence Memory(Measurement at 0, 6, 12, 18, 24 months)
- Change in Auditory Verbal Learning Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Picture Vocabulary(Measurement at 0, 6, 12, 18, 24 months)
- Change in Penn Digit Symbol Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in List Sorting Working Memory(Measurement at 0, 6, 12, 18, 24 months)
- Change in Positive and Negative Syndrome Scale, PANSS-6(Measurement at 0, 6, 12, 18, 24 months)
- Change in Oral Reading Recognition(Measurement at 0, 6, 12, 18, 24 months)
- Change in Penn Mouse Practice Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Penn Conditional Exclusion Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Penn Continuous Performance Test(Measurement at 0, 6, 12, 18, 24 months)
- Change in Managing Emotions(Measurement at 0, 6, 12, 18, 24 months)
研究者
Matcheri S. Keshavan MD
Stanley Cobb Professor and Academic Head of Psychiatry, Department of Psychiatry,
Beth Israel Deaconess Medical Center