Integrated cognitive behavior therapy to improve work outcomes in schizophrenia

描述(由申请人提供)： 1)背景：精神分裂症是一种毁灭性的疾病，每年给美国造成超过600亿美元的损失，主要原因是失业、生产力下降和其他功能不良的后果。职业康复计划，如支持性就业(SE)，可改善心理社会功能。然而，在我们机构中被诊断为精神分裂症相关的患者中，只有不到四分之一的人参与了SE，尽管它是可用的。我们开发了一种新的综合认知行为治疗(ICBT)团体治疗方案，专为低功能精神分裂症患者设计，以提高动机和对SE等心理社会康复计划的参与度。2)目的：本提案的目的是评估iCBT是否能够提高大多数功能残疾的精神分裂症患者参与现有SE计划的参与度和成功率。我们的主要目标是确定iCBT+SE是否会比心理教育(PE)+SE在更大程度上显著改善低功能精神分裂症患者的治疗后工作结果。我们的次要目标是评估iCBT+SE在6个月随访时是否比PE+SE显著改善工作结果，以及iCBT+SE是否相对于PE+SE改善治疗后和随访时的功能结果。3)研究设计：我们提出了一项前瞻性随机对照试验，参与者来自费城退伍军人医学中心(PVAMC)。我们将随机选择96名患者(每种情况48名患者)。评价员将对参与者治疗组的分配视而不见。评估课程将在基线、6个月、12个月和18个月进行。4)方法：纳入标准如下：1)诊断为精神分裂症或分裂情感障碍，2)严重功能残疾，3)最后一次住院至少90天，4)在PVAMC接受治疗，5)很少参与精神康复服务，6)18-65岁，7)精通英语，8)能够给予知情同意。排除标准是：1)神经疾病或损害，使精神分裂症的诊断值得怀疑，2)目前的阿片类药物或兴奋剂依赖。患有iCBT的患者将接受为期12个月的每周或每周两次的小组治疗。ICBT遵循Perivoliotis，Grant，&Beck开发的治疗手册。该手册详细说明了方法(参与、行为激活、认知补救/重组、维护)和个性化治疗计划。它还描述了处理积极和消极症状、情绪症状和自杀的策略和技术。它包括认知补救策略。33名被分配到PE的患者将接受为期12个月的每周或每周两次的小组会议。PE遵循PVAMC已经提供的基于证据的模式。这两种情况的患者都将参加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、精神科、病例管理)。主要的结果衡量标准将是治疗结束时工作行为问卷(WBI)的总分。次要结果指标为随访时的WBI总分和治疗后和6个月随访时测量的特定水平的功能量表(SLOF)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，并显著损害功能。在退伍军人管理局，我们有1300多名退伍军人患有精神分裂症或相关疾病。支持就业(SE)是一项在退伍军人管理局全国范围内实施的计划，因为大量证据表明，竞争性就业率提高，导致包括生活质量在内的其他方面的功能改善。然而，患有精神分裂症的退伍军人作为疾病的一部分，在动力方面有严重的障碍，尽管有SE，但通常不会参加SE。我们已经开发出一种综合认知-行为疗法(ICBT)，可以提高精神分裂症患者的动机。我们相信，通过将iCBT与SE配对，我们将提高SE的退伍军人参与率，导致更高的就业率，以及更好的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.