Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents

基于正念的青少年抑郁和胰岛素抵抗干预

• 批准号: 10705267
• 负责人: LAUREN BERGER SHOMAKER
• 金额: $ 65.62万
• 依托单位: COLORADO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10705267
• 关键词: Accounting; Adherence; Adolescent; Adult; Affect; Aftercare; American; Area; Behavior; Behavioral; Body Weight decreased; Cause of Death; Chronic Disease; Cognitive Therapy; Competence; Complementary Health; Control Groups; Data; Diabetes prevention; Disadvantaged; Disease; Eating; Educational Intervention; Effectiveness; Ethnic Origin; Face; Feasibility Studies; Female Adolescents; Focus Groups; Future; Geography; Health; Health Expenditures; Health education; Healthcare; Healthy Eating; High Prevalence; Hydrocortisone; Insulin Resistance; Integrative Medicine; Intervention; Learning; Life; Life Expectancy; Longterm Follow-up; Male Adolescents; Mental Depression; Methods; Mission; Modality; Modeling; National Center for Complementary and Integrative Health; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Overweight; Pattern; Persons; Physiological; Physiology; Pilot Projects; Preparation; Procedures; Protocols documentation; Public Health; Race; Randomized; Randomized, Controlled Trials; Research; Risk; Risk Factors; Role; Sampling; Site; Stress; Stressful Event; Target Populations; Testing; Time; Training; Work; acceptability and feasibility; active method; behavioral health; care costs; child depression; comorbidity; cost; cost effective intervention; depression model; depressive symptoms; diabetes risk; efficacy trial; experience; follow-up; hedonic; high risk; improved; innovation; intervention program; lifestyle intervention; meetings; mindfulness intervention; modifiable risk; novel; physical inactivity; prevent; programs; prospective; psychosocial; recruit; risk mitigation; socioeconomics; standard of care; stress reactivity; theories

Project Abstract/Summary Type 2 diabetes (T2D) is a serious chronic disease that affects 28 million Americans and costs $245 billion in annual U.S. healthcare expenditures. Although previously a disease limited to adulthood, of serious concern are studies showing that rates of adolescent-onset T2D are on the rise. Adolescent-onset T2D is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, the major physiological precursor to T2D. Unfortunately, standard-of-care behavioral lifestyle interventions to decrease insulin resistance through weight loss demonstrate insufficient effectiveness in adolescents, necessitating alternative approaches targeting novel risk factors. One novel modifiable risk factor is depression symptoms, a prospective risk factor for worsening insulin resistance and the onset of T2D over time, even after accounting for obesity. Depression likely promotes insulin resistance through stress-related behavior (e.g., hedonic eating, physical inactivity) and stress physiology (e.g., cortisol dysregulation, stress reactivity). In theory, mindfulness-based intervention (MBI) may be distinctively suited for adolescents at-risk for T2D through its potential to decrease depression symptoms, improve stress-related behavior and physiology, and thereby, improve insulin resistance and lessen T2D risk. To begin to test this approach, we completed a single-site, pilot randomized controlled trial (R00 HD069516) that established initial feasibility of recruitment, randomization, retention, protocol adherence, and acceptability/credibility of a 6-week group MBI program, Learning to BREATHE, among the target population. Compared to 6-week group cognitive-behavioral therapy (CBT; a standard-of-care depression intervention), MBI produced significantly greater decreases in depression symptoms and insulin resistance at 6-week/post-treatment follow-up and at 1-year follow-up in adolescents at- risk for T2D. Directly building upon our prior work, the proposed U01 study is a multisite, pilot randomized controlled trial implemented at four sites in preparation for a future multisite efficacy trial assessing the effects of 6-week group MBI, relative to another active treatment (CBT) and a didactic, health education control group (HealthEd), on depression and insulin resistance, as well as stress-related behavior and stress physiology. Specific aims of the current proposal are to: (1) Test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to adolescents at-risk for T2D with depression symptoms; (2) Evaluate multisite feasibility and acceptability of recruitment, retention, and adherence for a protocol involving randomization to 6- week group MBI, CBT, or HealthEd with 6-week/post-treatment follow-up and 1-year follow-up; and (3) Modify intervention training/implementation and protocol procedures in preparation for a future fully-powered multisite randomized controlled efficacy trial. Completion of these aims will prepare us to apply for a UG3/UH3 efficacy trial. Ultimately, this research will inform a complementary and integrative healthcare approach to adolescents at high-risk for T2D.

项目摘要/摘要 2型糖尿病（T2D）是一种严重的慢性疾病，影响2800万美国人，成本2450亿美元 年度美国医疗支出。尽管以前有一个疾病仅限于成年，但严重关注的是 研究表明，青少年发作的T2D发生率正在上升。青少年发作的T2D与 比成人发作的T2D更大的健康合并症和更短的预期寿命。 T2D可以通过减少来预防 胰岛素抵抗，T2D的主要生理前体。不幸的是，护理标准的行为生活方式 通过减肥来降低胰岛素抵抗的干预措施表明有效性不足 青少年，需要针对新风险因素的替代方法。一个新颖的可修改风险因素 是抑郁症状，是胰岛素抵抗恶化的前瞻性危险因素，T2D发作 时间，即使在考虑肥胖症之后。抑郁可能通过与应力相关促进胰岛素抵抗 行为（例如，享乐饮食，身体不活动）和压力生理学（例如皮质醇失调，压力 反应性）。从理论上讲，基于正念的干预措施（MBI）可能非常适合于青少年处于危险中 T2D通过减少抑郁症状，改善与压力相关的行为和生理学的潜力， 因此，提高胰岛素抵抗并降低T2D风险。为了开始测试这种方法，我们完成了一个 单点，飞行员随机对照试验（R00 HD069516），建立了招聘的初始可行性， 为期6周组MBI计划的随机化，保留，协议依从性以及可接受性/可接受性/可接受性/可接受性/可接受性， 在目标人群中学习呼吸。与6周的组认知行为疗法相比 （CBT；一种护理标准抑郁干预），MBI在抑郁症中产生的降低明显更大 在6周/治疗后的随访和1年随访的症状和胰岛素抵抗中 T2D的风险。直接基于我们先前的工作，拟议的U01研究是一项多站点的飞行员 在四个地点实施的对照试验为将来的多站点功效试验做准备，以评估 为期6周的MBI，相对于另一种活跃治疗（CBT）和教义，健康教育对照组 （健康），抑郁和胰岛素抵抗以及与压力相关的行为和压力生理学。 当前建议的具体目的是：（1）测试6周的培训和实施的多站点保真度 MBI组，CBT和Health已成为抑郁症状的T2D的青少年； （2）评估多站点 招募，保留和遵守的可行性和可接受性，涉及随机分组为6-- 每周MBI，CBT或健康的治疗后随访和1年随访； （3）修改 干预培训/实施和协议程序，为将来的全力以赴的多站点做准备 随机对照疗效试验。这些目标的完成将使我们准备申请UG3/UH3功效 审判。最终，这项研究将为青少年提供互补和综合的医疗保健方法 在高危的T2D处。