Cognitive Behavioral Skills Training for Schizophrenia

描述（由申请人提供）：精神分裂症影响超过200万美国人，并导致严重残疾。药物可以减少阳性症状，但不专门针对功能。功能结果显示，与认知障碍和社交技能缺陷的关系比与阳性症状的关系更强。心理社会干预结合药物治疗可以改善认知和社会功能，但适当的认知目标和干预技术的最佳组合尚不清楚。需要对通过减轻认知障碍和改善社区功能来扩大药物治疗的心理社会干预进行良好对照试验。我们开发，手动化和试点认知行为社交技能训练（CBSST），其目标是认知和元认知障碍，社交技能缺陷以及干扰精神分裂症患者功能的想法。拟定项目是一项比较CBSST与支持性接触（SC）的随机对照试验。精神分裂症患者（N=236）将被随机分配至2种疾病之一，治疗1年，并在治疗后纵向随访1年。多维度的结局评价将包括社会功能（主要结局）、神经心理功能、认知洞察力、精神症状和卫生服务利用。短期目标是研究CBSST对SC的有效性以及潜在的预测因素和变化机制。关键问题是：（1）在标准治疗中加入CBSST是否能改善精神分裂症患者相对于SC的康复结局？(2)基线时神经认知功能损害的严重程度或治疗中神经认知功能损害的改善是否能差异性地预测社会功能结局？(3)认知洞察力的改善是否介导CBSST中精神病性症状的改善？如果CBSST继续产生增量有效性，未来更大的有效性和传播试验将是合理的。

DESCRIPTION (provided by applicant): Schizophrenia affects more than 2 million Americans and leads to profound disability. Medications can reduce positive symptoms but do not specifically target functioning. Functional outcome shows stronger relationships with cognitive impairments and social skills deficits than with positive symptoms. Psychosocial interventions combined with pharmacotherapy can improve cognitive and social functioning, but the appropriate cognitive targets and optimal combination of intervention techniques are unclear. Well-controlled trials of psychosocial interventions that amplify pharmacotherapy by alleviating cognitive impairments and improving community functioning are needed. We developed, manualized and piloted cognitive-behavioral social skills training (CBSST), which targets cognitive and metacognitive impairments, social skills deficits, and thoughts that interfere with functioning in schizophrenia patients. The proposed project is a randomized controlled trial comparing CBSST with Supportive Contact (SC). Patients with schizophrenia (N=236) will be randomized to one of the 2 conditions, treated for 1 year and followed longitudinally for 1 year after treatment. A multi-dimensional evaluation of outcomes will include social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychiatric symptoms, and health services utilization. The short-term objectives are to examine the effectiveness of CBSST over SC and potential predictors and mechanisms of change. Key questions are: (1) Does adding CBSST to standard care improve rehabilitation outcomes relative SC in schizophrenia patients? (2) Does severity of neurocognitive impairment at baseline or improvement in neurocognitive impairment in treatment differentially predict social functioning outcome? (3) Does improvement in cognitive insight mediate improvement in psychotic symptoms in CBSST? If CBSST continues to produce incremental effectiveness, future larger effectiveness and dissemination trials would be justified.