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

概述这项研究测试了一种假设，即自主神经系统的失衡与许多 共鸣音调(战斗或逃跑)和少许副交感音调(休息、更新和社交参与)和 神经递质γ-氨基丁酸(GABA)活性低与阴性相关 情绪状态，可能是负面情绪和不良健康之间的关键潜在联系，因此 这些失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2期研究，纵向、有效、随机 对照试验。患有MDD的退伍军人将接受资格评估，并随机接受为期12周的干预 提供每周两次的瑜伽干预和连贯的呼吸，每次呼吸五次 每分钟或以每小时2.5英里的速度步行，这样这些群体在代谢需求、相互作用方面是匹配的 具有研究人员和团队效应。抑郁评定量表将在基线和第4、8、12周收集。 情绪量表和RSA将在基线以及干预前和干预后4、8和12周收集。 将在基线(扫描1)收集丘脑GABA水平的磁共振波谱(MRS)数据， 在为期12周的干预(扫描2)之后，立即进行指定的干预和扫描3。 主要的结果衡量标准是使用已建立的评级标准评估抑郁症状。这个 次要结果指标是丘脑GABA水平。第三结局的衡量标准是呼吸系统 窦性心律失常(RSA)，高频心率变异性的测量和副交感神经的标志 语气。评估旨在解决研究过程中的变化，以及之前的剧烈变化 在第4周、第8周和第12周的评估中进行干预。工具：抑郁量表包括汉密尔顿 抑郁评定量表-17(HDRS)和贝克抑郁量表II(BDI-II)。情绪量表包括 斯皮尔伯格状态-特质焦虑量表(STAI)和运动诱发感觉问卷(EIFI)。邮政 创伤应激障碍(PTSD)量表包括临床医生实施的创伤后应激量表 (CAPS)和创伤后应激障碍检查表-平民(PCL-C)。纳入标准：这项研究将包括18至65年 老年男性和女性目前被诊断为MDD的退伍军人，其HDRS评分从≥到14 放映。如果受试者一直在服用稳定剂量的抗抑郁药物，这些药物针对的是单胺系统 至少三个月，在研究期间没有预期的变化，他们将被允许继续他们的 药物治疗。排除标准：不允许有以下情况：精神病史或躁郁症病史 去年有自杀念头；目前的身心练习(如瑜伽、太极、气功、呼吸) 练习或冥想)；使用DSM-V对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，一种可能危及受试者的神经或医学状况 研究的安全性或完整性。失明：个体对抑郁量表进行评分，或分析MRS 并且RSA数据将对组分配视而不见。假设：I.A：瑜伽组，但不是散步组 从筛查到第12周，HDRS和BDI-II上的抑郁症状会有所减少。 尽管接受了稳定剂量(3个月)的治疗，但仍在基线水平上抑郁的受试者 在瑜伽组中，抗抑郁药物治疗会减少抑郁症状，但在步行组中不会。 1.C：如果处于基线状态，瑜伽中的创伤后应激障碍症状会有更大程度的减少 与散步组相比。他说：在三次扫描的过程中，GABA水平会有所上升 参加瑜伽班，但不参加散步组。3：在干预过程中以及从干预前到干预后 在第4周、第8周和第12周，情绪量表(STAI和EIFI)将有所改善，RSA将增加 参加瑜伽班，但不参加散步组。

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.