Integrated cognitive behavior therapy to improve work outcomes in schizophrenia

描述（由申请人提供）： 1)背景资料：精神分裂症是一种毁灭性的疾病，美国每年花费超过600亿美元，主要是由于失业，生产力损失和其他功能不良的后果。职业康复计划，如支持就业（SE），改善心理社会功能。然而，不到1/4的患者在我们的设施与精神分裂症相关的诊断参加SE，尽管它的可用性。我们已经开发了一种新的综合认知行为疗法（iCBT）团体治疗方案，旨在为低功能精神分裂症患者，以提高动机和参与社会心理康复计划，如SE。 2)目的：本提案的目的是评估iCBT是否可以改善大多数功能障碍的精神分裂症患者在现有SE计划中的参与度和成功率。我们的主要具体目标是确定iCBT + SE是否会在更大程度上显著改善低功能精神分裂症患者治疗后的工作成果。 我们的次要目的是评价iCBT + SE是否会显著改善6个月随访时相对于PE + SE的工作结局，以及iCBT + SE是否会改善治疗后和随访时相对于PE + SE的功能结局。 3)研究设计：我们提出了一项前瞻性随机对照试验，参与者从费城退伍军人医疗中心（PVAMC）招募。我们将随机分配96例患者（每种疾病48例患者）。 评估者将对受试者治疗组分配保持盲态。将在基线、6、12和18个月时进行评估。 4)方法学：研究入选标准如下：1）诊断为精神分裂症或情感性精神障碍，2）重度功能障碍，3）自上次住院至少90天，4）在PVAMC接受治疗，5）最低程度参与精神康复服务，6）年龄18-65岁，7）精通英语，8）能够提供知情同意。排除标准为：1）神经系统疾病或损害，使精神分裂症的诊断值得怀疑，2）目前阿片类药物或兴奋剂依赖。iCBT条件下的患者将接受每周或每周两次的小组会议，为期12个月。iCBT遵循由Perivoliotis，Grant和Beck开发的治疗手册。该手册详细介绍了方法（参与，行为激活，认知补救/重建，维护）和个性化治疗计划。它还描述了处理阳性和阴性症状，情绪症状和自杀倾向的策略和技术。33被分配到PE组的患者将接受每周或每周两次的小组治疗，持续12个月。PE遵循PVAMC已经提供的循证模型。 这两种情况的患者将参加PVAMC现有的SE计划。所有参与者将继续接受他们已经接受的任何服务（医疗、精神病、病例管理）。主要结局指标为治疗结束时工作行为量表（WBI）的总分。 次要结局指标将是随访时WBI的总分以及治疗后和6个月随访时测量的特定功能水平量表（SLOF）的总分。 公共卫生相关性： 精神分裂症是一种毁灭性的疾病，影响约1%的人口，并显着损害功能。在我们的退伍军人事务部，我们有超过1300名患有精神分裂症或相关疾病的退伍军人。支持就业（SE）是一项在弗吉尼亚州全国范围内实施的计划，因为大量证据表明竞争性就业率有所提高，从而改善了其他方面的功能，包括生活质量。然而，作为疾病的一部分，患有精神分裂症的退伍军人的动机会受到严重损害，尽管可以参加SE，但他们通常不会参加。我们开发了一种综合认知行为疗法（iCBT），可以提高精神分裂症患者的动力。我们相信，通过将iCBT与SE配对，我们将提高退伍军人对SE的参与，从而提高就业率，改善整体功能和生活质量。

DESCRIPTION (provided by applicant): 1) Background: Schizophrenia is a devastating illness that costs the US over $60 billion per year, mainly due to unemployment, lost productivity, and other consequences of poor functioning. Vocational rehabilitation programs such as Supported Employment (SE) improve psychosocial functioning. However, less than 1/4 of the patients at our facility with a schizophrenia-related diagnosis participate in SE despite its availability. We have developed a new integrated Cognitive Behavior Therapy (iCBT) group therapy protocol designed for low functioning patients with schizophrenia to improve motivation and engagement in psychosocial rehabilitation programs like SE. 2) Objectives: The objective of the current proposal is to evaluate whether iCBT can improve engagement and success in an existing SE program among the most functionally disabled patients with schizophrenia. Our primary specific aim is to determine whether iCBT + SE will significantly improve work outcomes at post- treatment to a greater extent than Psychoeducation (PE) + SE in low functioning patients with schizophrenia. Our secondary aims are to evaluate the whether iCBT + SE will significantly improve work outcomes at 6 month follow-up relative to PE + SE, and whether iCBT + SE will improve functional outcomes post-treatment and at follow-up relative to PE + SE. 3) Research Design: We are proposing a prospective randomized controlled trial with participants recruited from the Philadelphia VA Medical Center (PVAMC). We will randomize 96 patients (48 patients per condition). Assessors will be blinded to participant treatment group allocation. Assessment sessions will occur at baseline, and at 6, 12, and 18 months. 4) Methodology: The study inclusion criteria are as follows: 1) Diagnosis of schizophrenia or schizoaffective disorder, 2) Severe functional disability, 3) At least 90 days since last hospitalization, 4) Receiving treatmen at PVAMC, 5) Minimal engagement in psychiatric rehabilitation services, 6) Ages 18-65, 7) Proficient in English, 8) Able to give informed consent. Exclusion criteria are: 1) Neurologic disease or damage that would make the diagnosis of schizophrenia questionable, 2) Current opioid or stimulant dependence. Patients in the iCBT condition will receive weekly or twice weekly group sessions for 12 months. iCBT follows a treatment manual developed by Perivoliotis, Grant, & Beck. The manual details the approach (engagement, behavioral activation, cognitive remediation/restructuring, maintenance) and individualized treatment planning. It also describes strategies and techniques to deal with positive and negative symptoms, mood symptoms, and suicidality. It incorporates cognitive remediation strategies.33 Patients assigned to PE will receive weekly or twice weekly group sessions for 12 months. PE follows an evidence-based model already being delivered at the PVAMC. Patients in both conditions will participate in the existing SE program at PVAMC. All participants will continue to receive any services (medical, psychiatric, case management) they were already receiving. The primary outcome measure will be the total score on the Work Behavior Inventory (WBI) at the end of treatment. Secondary outcomes measures will be total score of the WBI at follow up and the total score on the Specific Levels of Functioning inventory (SLOF) measured at post-treatment and 6 month follow-up. PUBLIC HEALTH RELEVANCE: Schizophrenia is a devastating illness that affects about 1% of the population, and significantly impairs functioning. In our VA we have over 1300 Veterans with schizophrenia or related disorders. Supported Employment (SE) is a program that has been implemented nationally throughout the VA because of a large body of evidence demonstrating improved rates of competitive employment, leading to improvements in other aspects of functioning, including quality of life. However, Veterans with schizophrenia have major impairments in motivation as part of the illness, and often will not participate in SE despite its availability. We have developd a form of integrated cognitive-behavioral therapy (iCBT) that improves motivation in people with schizophrenia. We believe that by pairing iCBT with SE, we will improve Veteran participation in SE, leading to higher rates of employment, and better overall functioning and quality of life.