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

基本信息

批准号：
10028489
负责人：
LAUREN BERGER SHOMAKER
金额：
$ 76.32万
依托单位：
COLORADO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10028489
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 active method base child depression comorbidity cost cost effective depression model depressive symptoms diabetes risk effective intervention 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

项目摘要

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/总结 2 型糖尿病 (T2D) 是一种严重的慢性疾病，影响着 2800 万美国人，造成 2450 亿美元的损失美国每年的医疗保健支出。虽然以前是一种仅限于成年的疾病，但令人严重关注的是研究表明，青少年发病的 T2D 发病率正在上升。青少年发病的 T2D 与与成人发病的 T2D 相比，其健康合并症更多，预期寿命更短。 T2D 可通过减少胰岛素抵抗，T2D 的主要生理前兆。不幸的是，标准护理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在以下方面效果不足青少年，需要针对新的风险因素采取替代方法。一种新的可改变的风险因素抑郁症状是导致胰岛素抵抗恶化和 T2D 发病的潜在危险因素时间，即使考虑到肥胖因素。抑郁症可能通过压力相关促进胰岛素抵抗行为（例如享乐性饮食、缺乏身体活动）和应激生理学（例如皮质醇失调、压力反应性）。理论上，基于正念的干预（MBI）可能特别适合有以下风险的青少年： T2D 通过其减少抑郁症状、改善与压力相关的行为和生理机能的潜力，从而改善胰岛素抵抗并降低 T2D 风险。为了开始测试这种方法，我们完成了单中心试点随机对照试验 (R00 HD069516) 确定了招募的初步可行性，为期 6 周的团体 MBI 计划的随机化、保留、方案遵守情况和可接受性/可信度，在目标人群中学习呼吸。与 6 周团体认知行为治疗相比（CBT；标准护理抑郁症干预措施），MBI 显着减少抑郁症青少年在 6 周/治疗后随访和 1 年随访时的症状和胰岛素抵抗 T2D 的风险。拟议的 U01 研究直接建立在我们之前的工作基础上，是一项多地点、随机试验在四个地点进行对照试验，为未来评估效果的多地点疗效试验做准备 6 周组 MBI，相对于另一种积极治疗 (CBT) 和说教、健康教育对照组（健康教育），关于抑郁症和胰岛素抵抗，以及与压力相关的行为和压力生理学。当前提案的具体目标是： (1) 测试为期 6 周的培训和实施的多地点保真度 MBI、CBT 和 HealthEd 团体，针对有抑郁症状的 2 型糖尿病风险青少年； (2) 评估多站点涉及随机化至 6-的方案的招募、保留和遵守的可行性和可接受性周组 MBI、CBT 或 HealthEd，并进行 6 周/治疗后随访和 1 年随访； (3) 修改干预培训/实施和协议程序，为未来的全动力多站点做好准备随机对照疗效试验。完成这些目标将使我们准备好申请 UG3/UH3 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有 T2D 的高风险。