A Randomized Control Trial Treating Depression with Yoga and Coherent Breathing Versus Walking in Veterans

一项用瑜伽和连贯呼吸与步行治疗退伍军人抑郁症的随机对照试验

• 批准号: 10295164
• 负责人: Chris Conway Streeter
• 金额: --
• 依托单位: EDITH NOURSE ROGERS MEMORIAL VETERANS HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-10-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10295164
• 关键词: Acute; Address; Alcohol consumption; Antidepressive Agents; Anxiety; Autonomic nervous system; Beck depression inventory; Bipolar Disorder; Brain; Breathing; Breathing Exercises; Clinical; Control Groups; DSM-V; Data; Depressed mood; Diagnosis; Disease; Disease remission; Dose; Effectiveness; Eligibility Determination; Emotions; Equilibrium; Equipment and supply inventories; Evaluation; Exclusion Criteria; Exercise; Exhibits; Feasibility Studies; Feeling; Feeling suicidal; Female; Frequencies; Goals; Group Structure; Hamilton Rating Scale for Depression; Health; Healthcare; Hour; Individual; Intervention; Link; Magnetic Resonance Spectroscopy; Major Depressive Disorder; Matched Group; Measures; Medical; Meditation; Mental Depression; Metabolic; Moods; Neurologic; Neurotransmitters; Outcome Measure; Parasympathetic Nervous System; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Post-Traumatic Stress Disorders; Posture; Psychoses; Qi Gong; Randomized; Randomized Controlled Trials; Recording of previous events; Recurrence; Reporting; Research; Research Design; Residual state; Rest; Risk; Scanning; Sinus Arrhythmia; Substance Use Disorder; Suicide; Sympathetic Nervous System; Symptoms; System; Tai Ji; Testing; Thalamic structure; United States Department of Veterans Affairs; Veterans; Visually Impaired Persons; Walking; Yoga; alcohol use disorder; base; blind; body-mind; depressive symptoms; design; effective therapy; efficacy study; evidence base; fighting; gamma-Aminobutyric Acid; group intervention; heart rate variability; human old age (65+); inclusion criteria; innovation; instrument; male; military veteran; monoamine; negative emotional state; novel strategies; participant safety; post intervention; post-traumatic stress; post-traumatic symptoms; primary outcome; programs; respiratory; screening; secondary outcome; social engagement; symptomatic improvement; theories; trait; treatment group; walking intervention

Overview The study tests the hypothesis that an imbalance in the autonomic nervous system with to much sympathetic tone (Fight or Flight) and to little parasympathetic tone (rest, renewal and social engagement) and associated low activity in the neurotransmitter gamma aminobutyric acid (GABA) is associated with negative emotional states and may be a crucial underlying link between negative emotions and poor health such that the correction of these imbalances will be associated with decreased depressive symptoms in Veterans with Major Depressive Disorder (MDD). Study Design: This is a Phase 2, longitudinal, efficacy, randomized controlled trial. Veterans with MDD will be evaluated for eligibility and randomized to 12-week intervention providing two-sessions per week of either an intervention of yoga and coherent breathing at five breaths per minute or walking at 2.5 miles an hour, such that the groups are matched for metabolic demand, interaction with research staff and group effect. Depression scales will be collected at baseline and weeks 4, 8, and 12. Mood scales and RSA will be collected at baseline and pre and post interventions at weeks 4, 8, and 12. Magnetic resonance spectroscopy (MRS) data for thalamic GABA levels will be collected at baseline (Scan 1), after the 12-week intervention (Scan 2) which is immediately followed by the assigned intervention and Scan 3. The primary outcome measure is depression symptoms assessed using established rating scales. The secondary outcome measure is the thalamic GABA levels. The tertiary outcome measure is Respiratory Sinus Arrhythmia (RSA), a measure of high frequency Heart Rate Variability and a marker of parasympathetic tone. Evaluations are designed to address changes over the course of the study, and acute changes before and after interventions at week 4, 8, and 12 evaluations. Instruments: Depression scales include the Hamilton Rating Scale for Depression-17 (HDRS) and the Beck Depression Inventory II (BDI-II). Mood scales include the Spielberger State -Trait Anxiety Inventory (STAI) and the Exercise -Induced Feeling Inventory (EIFI). Post Traumatic Stress Disorder (PTSD) scales include the Clinician Administered Posttraumatic Stress Scale (CAPS) and the PTSD Check List – Civilian (PCL-C). Inclusion Criteria: The study will include 18 to 65 year old males and females Veterans with a current diagnosis of MDD who have a HDRS scores ≥ to 14 at screening. If subjects have been taking a stable dose of antidepressants that target a monoamine system for at least three months with no anticipated changes during the study, they will be allowed to continue their medication. Exclusion Criteria: The following are not allowed: history of psychosis or bipolar illness; history of suicidal ideation with intent in the last year; current mind-body practice (e.g., yoga, Tai Chi, Qigong, breathing practices, or meditation); more than three current criteria for Alcohol or Substance Use Disorder using DSM-V criteria; a current Substance Use Disorder, a neurologic or medical condition that could compromise subject safety or the integrity of the study. Blinding: Individuals scoring the depression scales, or analyzing the MRS and RSA data will be blind to group assignment. Hypothesis: I.a: The yoga group but not the walking group will show decreased in depressive symptoms on the HDRS and BDI-II from screening to week 12. 1.b: Subjects who are still depressed at baseline despite treatment with a stable dose (> 3 months) of antidepressants treatment will show decreased depressive symptoms in the yoga but not the walking group. 1.c: If present at baseline, there will be a greater decrease in PTSD symptoms on the CAPS in the yoga compared to the walking group. 2: There will be an increase in GABA levels over the course of the three scans in the yoga but not the walking group. 3: Over the course of the intervention and from pre to post-intervention at weeks 4, 8, and 12 there will be an improvement in the mood scales (STAI and EIFI), and increase in RSA in the yoga but not the walking group.

概述这项研究测试了一个假设，即自主神经系统的不平衡， 交感神经紧张（战斗或逃跑）和小副交感神经紧张（休息，更新和社会参与）， 神经递质γ-氨基丁酸（GABA）的相关低活性与负相关 情绪状态，可能是负面情绪和健康状况不佳之间的关键潜在联系， 这些不平衡的纠正将与退伍军人抑郁症状的减少有关， 重度抑郁症（MDD）。研究设计：这是一项II期、纵向、疗效、随机 对照试验将评估MDD退伍军人的合格性，并随机分配至12周干预组 每周提供两次瑜伽和连贯呼吸的干预，每次五次呼吸， 每分钟或以每小时2.5英里的速度步行，这样各组的代谢需求、相互作用 研究人员和群体效应。将在基线和第4、8和12周收集抑郁量表。 将在基线以及干预前后第4、8和12周收集情绪量表和RSA。 将在基线（扫描1）时收集丘脑GABA水平的磁共振波谱（MRS）数据， 12周干预（扫描2）后，紧接着进行指定干预和扫描3。 主要结果测量是使用已建立的评定量表评估抑郁症状。的 次要结果测量是丘脑GABA水平。第三个结局指标是呼吸 窦性心律失常（RSA），一种高频心率变异性的测量方法和副交感神经系统的标志物 语气评估旨在解决研究过程中的变化，以及研究前的急性变化。 以及干预后第4、8和12周的评价。工具：抑郁量表包括汉密尔顿量表 抑郁量表-17（HDRS）和贝克抑郁量表II（BDI-II）。情绪量表包括 Spielberger状态-特质焦虑量表（STAI）和运动诱发感觉量表（EIFI）。邮政 创伤性应激障碍（PTSD）量表包括临床医生管理的创伤后应激量表 （CAPS）和PTSD检查表-平民（PCL-C）。入选标准：该研究将包括18至65岁 当前诊断为MDD的老年男性和女性退伍军人，在 筛选如果受试者一直服用稳定剂量的抗抑郁药，靶向单胺系统， 如果在研究期间没有预期的变化，他们将被允许继续他们的研究。 药排除标准：不允许有以下情况：精神病或双相情感障碍病史; 过去一年内有自杀意念;目前的身心实践（例如，瑜伽，太极，气功，呼吸 实践，或冥想）;使用DSM-V的酒精或物质使用障碍的三个以上当前标准 标准;当前物质使用障碍，可能损害受试者的神经或医学状况 研究的安全性或完整性。设盲：个体对抑郁量表进行评分，或分析MRS 并且RSA数据将对组分配不知情。假设：I.a：瑜伽组，而不是步行组 从筛选至第12周，HDRS和BDI-II显示抑郁症状减轻。1.b： 尽管用稳定剂量（> 3个月）的抗抑郁药治疗，但在基线时仍然抑郁的受试者 抗抑郁药物治疗会减少瑜伽组的抑郁症状，但步行组则不然。 1.c：如果在基线时存在，瑜伽中CAPS上的PTSD症状将有更大的减少 与步行组相比。2：在三次扫描过程中，GABA水平会增加 瑜伽组但步行组不行3：在干预过程中以及从干预前到干预后 在第4、8和12周，情绪量表（STAI和EIFI）将有所改善，RSA增加 参加瑜伽组，但不参加步行组。