Exploring CBT-DM's Absoulte and Relative Efficacy for Depressed T1DM Latino Youth

描述（由申请人提供）：这是提交给NIDDK的R03 （PAR-09-223）申请。本研究修订了针对拉丁裔青年抑郁型1型糖尿病（T1DM）的12期群体认知行为治疗（CBT- dm）手册，并探讨了CBT- dm对常规治疗（TAU）的绝对疗效，以及CBT- dm对抑郁的原始文化适应性CBT的额外影响。在我们的专家团队对手册进行初步修订后，我们将对糖尿病治疗提供者进行深入访谈，并对8名患有抑郁症的拉丁裔T1DM青年及其父母进行小型预试点研究，为CBT-DM治疗手册的修订和进一步完善提供信息。在小规模的预先试点研究中，青年和家长的焦点小组将有助于完成改进过程。最后，60名患有抑郁症的T1DM青年将被随机分为三组：CBT- dm、CBT治疗抑郁症和TAU。治疗效果将通过比较T1DM患者抑郁、自尊和功能评分、糖尿病自我效能感和生活质量、治疗依从性和自我护理管理的变化来评估。我们认为CBT- dm和CBT在减少抑郁、改善自尊和功能方面都优于TAU。我们还假设CBT-DM在与T1DM相关的领域（糖尿病自我效能、生活质量、治疗依从性和自我护理行为）优于其他条件。摄入数据将通过结构化诊断访谈、自我报告量表和糖化血红蛋白（HbA1c）的实验室测试获得。我们将评估青少年T1DM健康和治疗依从性信息，心理健康（包括抑郁症）诊断状况，青少年认知和情感变量，父母和家庭功能，以及家庭对青少年抑郁症和T1DM的了解。我们还将评估治疗的可行性和可接受性、随机化的充分性、损耗率、治疗师的能力和治疗的完整性。评估将在基线、第5周、第9周和第12周（治疗后）以及3个月和6个月随访时进行。本研究是一项研究项目的第二步，旨在为拉美裔青年合并T1DM和抑郁症患者带来循证治疗（EBT）的益处，并为更大规模、更明确的治疗效果研究奠定基础（R01）。这项研究具有创新性，因为它是第一个可能有助于提供初步证据，支持旨在改善糖尿病健康状况和减少青少年抑郁症状的社会心理干预可能有效的状态。针对拉丁裔T1DM青年修订的CBT-DM手册也将是一种创新的临床工具，可以加强对情绪障碍的预防，并减少这一少数群体的健康差异。

DESCRIPTION (provided by applicant): This is an R03 (PAR-09-223) application submitted to NIDDK. This study entails the revision of the 12-session Group Cognitive Behavioral Therapy (CBT-DM) manual for depressed Type 1 Diabetes Mellitus (T1DM) Latino youth, and explores both the absolute efficacy of CBT-DM against a treatment as usual (TAU) condition, and the added impact of CBT-DM over the original culturally-adapted CBT for depression. After initial manual revision by our expert team, in-depth interviews with diabetes treatment providers, and a small pre-pilot study with 8 depressed T1DM Latino youth and their parents will be conducted to inform the revision of and further refine CBT-DM treatment manual. Focus groups with youth and parents in the small pre-pilot study will serve to complete the refinement process. Finally, 60 depressed T1DM youth will be randomized to one of three conditions: CBT-DM, CBT for depression, and TAU. Treatment efficacy will be assessed by comparing changes on depression, self-esteem and functionality scores, diabetes self-efficacy and quality of life, and treatment adherence and self-care management of T1DM. We propose that both CBT-DM and CBT will be superior to TAU in reducing depression, and improving self-esteem and functionality. We also hypothesize that CBT-DM will be superior to the other conditions in domains related to T1DM (diabetes self-efficacy, quality of life, treatment adherence and self-care behaviors). Intake data will be obtained with structured diagnostic interviews, self-report scales and laboratory tests of glycosylated hemoglobin (HbA1c). We will assess youth T1DM health and treatment adherence information, mental health (including depression) diagnostic status, youth cognitive and affective variables, parent and family functioning, and family knowledge about youth depression and T1DM. We will also evaluate the feasibility and acceptability of treatment, the adequacy of randomization, attrition rates, therapist competence and treatment integrity. The assessment will be conducted at baseline, at weeks 5, 9 and 12 (post-treatment), and at the three- and six-month follow-ups. This investigation is the second step in a research program aimed to bring the benefits of evidence-based treatment (EBT) development to Latino youth with comorbid T1DM and depression, and set the stage for a larger-scale and definite study of treatment efficacy (R01). This study is innovative because it is the first that could potentially contribute to provide initial evidence in support of the probably-efficacious status of a psychosocial intervention aimed at both improving diabetes health status and reducing depressive symptoms in youth. The revised CBT-DM manual for T1DM Latino youth would also be an innovative clinical tool that could enhance the prevention of mood disorders and the reduction of health disparities in this minority group.