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: 10475324
• 负责人: LAUREN BERGER SHOMAKER
• 金额: $ 47.85万
• 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/10475324
• 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; 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; 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; 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; 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(T2D)是一种严重的慢性疾病，影响着2800万美国人，在美国造成2450亿美元的损失 美国年度医疗支出。尽管以前是一种仅限于成年的疾病，但令人严重关切的是 研究表明，青春期T2D的发病率正在上升。青春期起病的T2D与 与成人发病的T2D相比，更多的健康合并症和更短的预期寿命。T2D是可以通过减少 胰岛素抵抗，是T2D的主要生理前驱。不幸的是，标准护理的行为生活方式 通过减肥来降低胰岛素抵抗的干预措施显示在 青少年，有必要采取针对新风险因素的替代办法。一种新的可修改的风险因素 抑郁症状是胰岛素抵抗恶化和T2D发病的潜在危险因素吗？ 时间，即使在考虑到肥胖之后。抑郁症可能通过与压力相关的方式促进胰岛素抵抗 行为(如享乐主义饮食、缺乏运动)和压力生理(如皮质醇失调、压力 反应性)。从理论上讲，以正念为基础的干预(MBI)可能特别适合高危青少年。 T2D通过其潜在的减轻抑郁症状，改善与压力相关的行为和生理， 从而改善胰岛素抵抗，降低T2D风险。为了开始测试这种方法，我们完成了一个 确定了招募的初步可行性的单地点、试点随机对照试验(R00 HD069516)， 为期6周的小组MBI计划的随机性、保留率、方案遵从性和可接受性/可信度， 在目标人群中学习呼吸。与为期6周的团体认知行为疗法相比 (CBT；一种标准护理抑郁症干预)，MBI对抑郁症的下降幅度要大得多 青少年在6周/治疗后和1年随访时的症状和胰岛素抵抗- T2D的风险。建议的U01研究直接建立在我们先前工作的基础上，是一项多点、随机试点的研究 在四个地点实施对照试验，为未来的多地点疗效试验做准备，以评估 6周MBI组，相对于另一种积极治疗(CBT)和说教健康教育对照组 (Healed)，关于抑郁和胰岛素抵抗，以及与压力相关的行为和压力生理学。 目前提议的具体目标是：(1)测试多地点培训的保真度，并实施为期6周的培训 将MBI、CBT和Healed分组，用于T2D伴抑郁症状的高危青少年；(2)多点评估 招募、保留和遵守协议的可行性和可接受性，该协议涉及随机到6- 周组MBI、CBT或康复组6周/治疗后随访和1年随访；(3)修改 为未来的全动力多站点做准备的干预培训/实施和协议程序 随机对照疗效试验。完成这些目标将为我们申请UG3/UH3疗效做好准备 审判。最终，这项研究将为青少年提供补充和综合的保健方法 处于T2D的高危状态。