Intervention for Menstrual Mood Disorders & Early Life Abuse: Biopsych Mechanisms

经期情绪障碍的干预

• 批准号: 8727665
• 负责人: SUSAN S. GIRDLER
• 金额: $ 66.21万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-28 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8727665
• 关键词: Adherence; Adrenal Glands; Affect; Affective; Aftercare; Anxiety; Arousal; Awareness; Baroreflex; Behavior Therapy; Biological; Biological Factors; Blood Pressure; Cardiac; Control Groups; Corticotropin; Data; Diagnosis; Diagnostic; Diagnostic and Statistical Manual of Mental Disorders; Disease; Effectiveness; Emotions; Epinephrine; Event; Functional disorder; Genetic Crossing Over; Goals; Health education; Heart Rate; Heating; Hydrocortisone; Hyperalgesia; Hypothalamic structure; Impairment; Inflammation; Inflammatory; Interleukin-6; Intervention; Knowledge; Laboratories; Life; Link; Luteal Phase; Mediating; Mediator of activation protein; Menstrual cycle; Mental Depression; Modeling; Modification; Molecular; Mood Disorders; Moods; Morbidity - disease rate; National Institute of Mental Health; Neurobiology; Norepinephrine; Outcome; Outcome Measure; Pain; Pathway interactions; Pharmacotherapy; Phase; Phenotype; Physiological; Pituitary Gland; Plasma; Procedures; Process; Psyche structure; Psychological Factors; Psychopathology; Randomized; Recording of previous events; Recurrence; Regulation; Research; Research Domain Criteria; Rest; Severities; Speed; Stimulus; Stress; Sympathetic Nervous System; Symptoms; Syndrome; System; Testing; Training; Treatment Efficacy; Woman; Work; base; biobehavior; biopsychosocial; central pain; depressive symptoms; evidence base; experience; functional disability; improved functioning; indexing; lens; meetings; mindfulness; mindfulness-based stress reduction; neurophysiology; post intervention; premenstrual dysphoric disorder; primary outcome; programs; prospective; psychologic; public health relevance; response; secondary outcome; therapeutic target; trait; treatment effect

DESCRIPTION (provided by applicant): Early life abuse (ELA) impacts neurobiological systems that regulate stress, arousal and emotion. As such, ELA represents an environmental event altering fundamental mechanisms that cut across a variety of psychopathologies. Menstrually related mood disorders (MRMDs), including premenstrual dysphoric disorder (PMDD), are defined by the cyclic recurrence of affective and somatic/pain symptoms and impairment during the luteal phase of the menstrual cycle. MRMDs are associated with high rates of ELA and represent a model of psychopathology whose pathophysiologic underpinnings are linked to ELA. The primary objective of this application is to test predictors and biobehavioral mechanisms of efficacy of a behavioral intervention for MRMDs. Mindfulness based stress reduction (MBSR) is a promising intervention with evidence for beneficial modulation of stress, arousal and emotion. We hypothesize, based on the evidence that MRMD women with ELA have more severe symptoms, dysregulation in stress reactivity, and greater pain sensitivity than MRMD women without ELA, that MBSR will be efficacious in reducing symptoms, functional impairment and pain sensitivity in women with MRMD, especially in those with ELA. Our secondary objective is to examine biopsychosocial mediators of efficacy, thus advancing our understanding of pathophysiological mechanisms in MRMD and other disorders with high rates of ELA and aiding in the identifying therapeutic targets. 120-130 women meeting prospective criteria for a MRMD will be randomized (stratified on ELA and baseline premenstrual depression severity) to either the 8-week MBSR program or to an 8-week Health Education Program (HEP) Control Group. Primary outcome measures are: 1) premenstrual depression symptomatology assessed prospectively throughout the intervention; 2) functional impairment; and 3) sensitivity to cold pressor pain. If hypotheses for primary outcomes are supported, secondary outcome measures involving premenstrual anxiety, irritability and total symptom severity as well as sensitivity to the temporal summation of heat pain procedure (indexing central pain processing) will be examined. In the laboratory (before and after the intervention), predicted biological mediators of MBSR efficacy will be assessed at rest and in response to mental stress: 1) sympathetic nervous system (blood pressure, heart rate, plasma norepinephrine and epinephrine); 2) hypothalamic-pituitary-adrenal (plasma ACTH and cortisol); 3) inflammatory (plasma IL-6); and 4) cardiac autonomic control (baroreceptor reflex sensitivity). Predicted psychological mediators of treatment efficacy are: 1) trait mindfulness; 2) acceptance; and 3) rumination, assessed before, at the mid-point, and after the intervention. Following the 8 week intervention, women will be followed for 6 months to assess sustainability of beneficial outcomes. Outcomes will be as for the intervention phase: daily symptom ratings, function and pain sensitivity (tested at months 3 and 6), as well as adherence.

描述（由申请人提供）：早期生活虐待（ELA）会影响调节压力、唤醒和情绪的神经生物学系统。因此，ELA 代表了一种环境事件，它改变了跨越各种精神病理学的基本机制。月经相关情绪障碍 (MRMD)，包括经前烦躁障碍 (PMDD)，是指月经周期黄体期期间情感和躯体/疼痛症状的周期性复发和损伤。 MRMD 与高 ELA 发生率相关，代表了一种精神病理学模型，其病理生理学基础与 ELA 相关。此应用程序的主要目的是测试 MRMD 行为干预功效的预测因素和生物行为机制。基于正念的减压（MBSR）是一种很有前途的干预措施，有证据表明可以有益地调节压力、唤醒和情绪。基于证据表明，与没有 ELA 的 MRMD 女性相比，患有 ELA 的 MRMD 女性有更严重的症状、应激反应失调和更高的疼痛敏感性，我们假设 MBSR 将有效减轻 MRMD 女性的症状、功能障碍和疼痛敏感性，尤其是那些患有 ELA 的人。我们的次要目标是检查疗效的生物心理社会调节因素，从而增进我们对 MRMD 和其他 ELA 发生率高的疾病的病理生理机制的理解，并帮助确定治疗靶点。 120-130 名符合 MRMD 前瞻性标准的女性将被随机分配到为期 8 周的 MBSR 计划或为期 8 周的健康教育计划 (HEP) 对照组（根据 ELA 和基线经前抑郁严重程度进行分层）。主要结果指标是：1）在整个干预过程中前瞻性评估经前抑郁症症状； 2）功能障碍； 3) 对冷压疼痛敏感。如果主要结果的假设得到支持，则将检查次要结果指标，包括经前焦虑、易怒和总体症状严重程度以及对热痛过程的时间总和的敏感性（索引中枢疼痛处理）。在实验室中（干预前后），将在休息时和对精神压力的反应中评估 MBSR 功效的预测生物介质：1）交感神经系统（血压、心率、血浆去甲肾上腺素和肾上腺素）； 2）下丘脑-垂体-肾上腺（血浆ACTH和皮质醇）； 3) 炎症（血浆IL-6）； 4）心脏自主控制（压力感受器反射敏感性）。治疗效果的预测心理调节因素包括：1）特质正念； 2）验收； 3) 沉思，在干预前、干预中和干预后进行评估。经过 8 周的干预后，将对女性进行为期 6 个月的跟踪，以评估有益结果的可持续性。结果将与干预阶段相同：每日症状评级、功能和疼痛敏感性（在第 3 个月和第 6 个月进行测试）以及依从性。