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: 10261450
• 负责人: LAUREN BERGER SHOMAKER
• 金额: $ 71.21万
• 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/10261450
• 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; Event; Face; Feasibility Studies; Female Adolescents; Focus Groups; Future; Geography; Health; Health Care Costs; Health Expenditures; Health education; Healthcare; Healthy Eating; High Prevalence; Hydrocortisone; Insulin; Insulin Resistance; Integrative Medicine; Intervention; Learning; Life; Life Expectancy; Longterm Follow-up; Male Adolescents; Mental Depression; Methods; Mission; Modality; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Overweight; Pattern; Physiological; Physiology; Pilot Projects; Preparation; Procedures; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Research; Risk; Risk Factors; Role; Sampling; Site; Stress; Target Populations; Testing; Time; Training; Work; acceptability and feasibility; active method; base; 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; mindfulness intervention; modifiable risk; novel; physical inactivity; prevent; programs; prospective; psychosocial; racial and ethnic; recruit; 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（T2 D）是一种严重的慢性疾病，影响2800万美国人，每年花费2450亿美元。 美国每年的医疗支出。虽然以前这种疾病仅限于成年人，但令人严重关切的是， 研究表明，糖尿病发病率呈上升趋势。青少年发作的T2 D与以下因素相关： 与成人发病的T2 D相比，健康合并症更多，预期寿命更短。T2 D可以通过减少 胰岛素抵抗，T2 D的主要生理前体。不幸的是，标准治疗的行为生活方式 通过减轻体重来降低胰岛素抵抗的干预措施在以下方面的效果不足： 青少年，需要针对新的风险因素采取替代办法。一个新的可改变的风险因素 是抑郁症状，是胰岛素抵抗恶化和T2 D发作的潜在风险因素， 时间，即使在考虑肥胖之后。抑郁症可能通过与压力相关的 行为（例如，享乐饮食，身体不活动）和应激生理学（例如，皮质醇失调，应激 反应性）。从理论上讲，基于正念的干预（MBI）可能特别适合有以下风险的青少年： T2 D通过其减少抑郁症状，改善压力相关行为和生理的潜力， 从而改善胰岛素抵抗并降低2型糖尿病风险。为了开始测试这种方法，我们完成了一个 单中心、初步随机对照试验（R 00 HD 069516），确定了招募的初步可行性， 6周小组MBI项目的随机化、保留、方案依从性和可接受性/可信度， 在目标人群中学习呼吸。与6周认知行为治疗组相比， (CBT标准治疗抑郁症干预），MBI产生了显着更大的减少抑郁症 - 治疗后6周随访和1年随访时青少年的症状和胰岛素抵抗 T2 D风险直接基于我们之前的工作，拟定的U 01研究是一项多中心、初步随机化研究 在四个研究中心进行对照试验，为未来的多中心疗效试验做准备， 6-一周组MBI，相对于另一种积极治疗（CBT）和一个教学，健康教育对照组 （健康教育），抑郁症和胰岛素抵抗，以及压力相关的行为和压力生理学。 目前建议的具体目标是：（1）测试培训和实施6周的多地点保真度 MBI、CBT和HealthEd组，针对有抑郁症状的T2 D风险青少年;（2）评估多部位 招募、保留和依从性的可行性和可接受性，包括随机分配至6- 周组MBI、CBT或HealthEd，6周/治疗后随访和1年随访;以及（3）修改 干预培训/实施和协议程序，为未来的全动力多站点做准备 随机对照疗效试验。这些目标的完成将使我们准备申请UG 3/UH 3功效 审判最终，这项研究将为青少年提供补充和综合的医疗保健方法 患T2 D的高危人群