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

描述(申请人提供)：这是一份提交给NIDDK的R03(PAR-09-223)申请。这项研究需要修订12节的针对抑郁的1型糖尿病(T1 DM)拉丁裔青年的团体认知行为治疗(CBT-DM)手册，并探索CBT-DM相对于常规治疗(TAU)的绝对疗效，以及CBT-DM相对于最初适应文化的CBT治疗抑郁症的额外影响。在我们的专家团队对手册进行初步修订后，我们将与糖尿病治疗提供者进行深入访谈，并对8名患有抑郁症的T1 DM拉丁裔青年及其父母进行小型试点研究，以告知修订和进一步完善CBT-DM治疗手册的情况。在试点前的小型研究中，与青少年和家长组成的重点小组将有助于完成完善过程。最后，60名抑郁的T1 DM青年将被随机分为三种情况：CBT-DM、CBT抑郁症和TAU。治疗效果将通过比较抑郁、自尊和功能评分、糖尿病自我效能和生活质量以及T1 DM患者的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在减轻抑郁、提高自尊和功能方面都优于TAU。我们还假设，CBT-DM在与T1 DM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)将优于其他条件。摄入量数据将通过结构化诊断性访谈、自我报告量表和糖化血红蛋白(HbA1c)实验室测试获得。我们将评估青少年T1 DM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T1 DM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、流失率、治疗师的能力和治疗的完整性。评估将在基线、第5、9和12周(治疗后)以及3个月和6个月的后续行动中进行。这项调查是一项研究计划的第二步，该计划旨在为患有T1 DM和抑郁症的拉美裔青年带来循证治疗(EBT)发展的好处，并为更大规模和明确的治疗效果研究(R01)奠定基础。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年抑郁症状的心理社会干预可能有效的状态。为T1 DM拉丁裔青年修订的CBT-DM手册也将是一种创新的临床工具，可以加强这一少数群体中情绪障碍的预防和减少健康差距。

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.