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

探索 CBT-DM 对抑郁 T1DM 拉丁裔青年的绝对和相对功效

• 批准号: 8175970
• 负责人: Eduardo Cumba
• 金额: $ 18.4万
• 依托单位: UNIVERSITY OF PUERTO RICO RIO PIEDRAS
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8175970
• 关键词: Address; Adherence; Administrator; Adolescent; Affect; Affective; Aftercare; Age; Behavior; Behavioral; Blindness; Blood; Blood Glucose; Cessation of life; Child; Childhood; Chronic Disease; Clinical; Cognitive; Cognitive Therapy; Coma; Competence; Complications of Diabetes Mellitus; Data; Depressed mood; Diabetes Mellitus; Diagnosis; Diagnostic; Early identification; Early treatment; Employee Strikes; Evidence based intervention; Evidence based treatment; Exercise; Expenditure; Family; Focus Groups; Glycosylated Hemoglobin; Glycosylated hemoglobin A; Goals; Health; Health Personnel; Health Status; Heart Diseases; Hispanics; Hormones; Hyperglycemia; Hypertension; Immune system; Incidence; Injection of therapeutic agent; Insulin; Insulin-Dependent Diabetes Mellitus; Intake; Intervention; Interview; Investigation; Kidney Failure; Knowledge; Laboratories; Latino; Lead; Life; Light; Long-Term Effects; Manuals; Medical; Mental Depression; Mental Health; Metabolic Control; Minority Groups; Monitor; Mood Disorders; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Nature; Nerve; Not Hispanic or Latino; Onset of illness; Outcome; Parents; Participant; Patient Self-Report; Pilot Projects; Population; Prevalence; Prevention; Primary Health Care; Procedures; Process; Puerto Rican; Puerto Rico; Quality of life; Randomized; Randomized Clinical Trials; Regimen; Registries; Relative (related person); Research; Risk; Self Care; Self Efficacy; Staging; Structure; Structure of beta Cell of islet; Testing; Time; Training; Treatment Efficacy; Youth; depressive symptoms; design; diabetes education; diabetes management; diabetic; follow-up; glucose monitor; health disparity; improved; innovation; novel; pilot trial; prevent; programs; psychosocial; self esteem; therapy development; tool; treatment adherence; treatment as usual; young adult

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. PUBLIC HEALTH RELEVANCE: This study is likely to shed light on whether a novel intervention combining CBT with diabetes education for youth can reduce the morbidity observed in those with co-morbid T1DM and depression and achieve positive diabetes outcomes, as opposed to Treatment as usual (TAU) and CBT for depression. It will be the first to develop/adapt and pilot-test (in a small Randomized Clinical Trial-type design) a culturally-sensitive intervention specifically tailored to Latino youth with co-morbid T1DM and depression, and if proven to be promising, it will make it attractive for administrators to implement it in primary care and mental health settings serving the Latino pediatric population. This research will potentially help to close knowledge gaps in treatment research with T1DM Latino children and impact other behavioral, cognitive, and affective factors that add on the burden of diabetes in this vulnerable and underserved group.

描述（由申请人提供）：这是提交给NIDDK的R 03（PAR-09-223）申请。这项研究需要修订12届小组认知行为治疗（CBT-DM）手册抑郁症1型糖尿病（T1 DM）拉丁裔青年，并探讨CBT-DM对治疗照常（TAU）条件的绝对疗效，以及CBT-DM对抑郁症的原始文化适应CBT的额外影响。在我们的专家团队进行初步手册修订后，将对糖尿病治疗提供者进行深入访谈，并对8名抑郁的T1 DM拉丁裔青年及其父母进行小型预试验研究，以了解CBT-DM治疗手册的修订和进一步完善。在小型试点前研究中与青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青年将被随机分配到三种情况之一：CBT-DM，CBT抑郁症和TAU。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的治疗依从性和自我护理管理的变化来评估治疗疗效。我们认为CBT-DM和CBT在减少抑郁、提高自尊和功能方面都上级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）上级其他疾病。将通过结构化诊断访谈、自我报告量表和糖化血红蛋白（HbA 1c）实验室检查获得摄入数据。我们将评估青年T1 DM健康和治疗依从性信息，心理健康（包括抑郁症）诊断状态，青年认知和情感变量，父母和家庭功能，以及家庭对青年抑郁症和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、损耗率、治疗师的能力和治疗的完整性。将在基线、第5、9和12周（治疗后）以及3个月和6个月随访时进行评估。这项调查是一项研究计划的第二步，旨在为患有T1 DM和抑郁症的拉丁裔青年带来循证治疗（EBT）发展的益处，并为更大规模和明确的治疗疗效研究（R 01）奠定基础。这项研究是创新的，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的可能有效状态。修订后的T1 DM拉丁裔青年CBT-DM手册也将是一个创新的临床工具，可以加强预防情绪障碍和减少这一少数群体的健康差距。 公共卫生相关性：这项研究可能揭示了一种新的干预措施，将CBT与青年糖尿病教育相结合，是否可以降低合并T1 DM和抑郁症患者的发病率，并实现积极的糖尿病结局，而不是像往常一样治疗（TAU）和CBT治疗抑郁症。这将是第一个开发/适应和试点测试（在一个小型随机临床试验类型的设计）一个文化敏感的干预措施，专门针对患有合并症的T1 DM和抑郁症的拉丁美洲青年，如果被证明是有前途的，它将使管理员有吸引力，在初级保健和精神卫生环境中实施它，为拉丁美洲儿科人群服务。这项研究可能有助于缩小T1 DM拉丁裔儿童治疗研究中的知识差距，并影响其他行为，认知和情感因素，这些因素增加了这个脆弱和服务不足群体的糖尿病负担。