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

经期情绪障碍的干预

• 批准号: 8578260
• 负责人: SUSAN S. GIRDLER
• 金额: $ 73.7万
• 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/8578260
• 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; 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; 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）：早期生命虐待（ELA）会影响调节压力，唤醒和情感的神经生物学系统。因此，ELA代表了一个环境事件，改变了跨越各种心理病理学的基本机制。月经障碍（包括经前烦躁不安障碍（PMDD））的月经情绪障碍（MRMDS）是由情感和体细胞/疼痛症状的循环复发以及月经周期的黄体期间的损害来定义的。 MRMD与高ELA率有关，代表了心理病理学模型，其病理生理基础与ELA有关。该应用的主要目的是测试MRMDS行为干预功效的预测因子和生物行为机制。基于正念的压力减轻（MBSR）是一种有希望的干预措施，有证据表明压力，唤醒和情感的有益。我们基于以下证据，表明患有ELA的MRMD女性具有更严重的症状，压力反应性的失调以及比没有ELA的MRMD妇女更大的疼痛敏感性，MBSR将有效减轻症状，功能障碍和MRMD女性的疼痛敏感性，尤其是ELA患者。我们的次要目标是检查疗效的生物心理社会介体，从而促进我们对MRMD的病理生理机制的理解和其他ELA率高并有助于识别治疗靶标的疾病的理解。 120-130符合MRMD的前瞻性标准的妇女将被随机分组​​（在ELA和基线前抑郁症严重程度上分层）为8周的MBSR计划或为期8周的健康教育计划（HEP）对照组。主要结局指标是：1）在整个干预过程中对前瞻性评估的经前抑郁症状； 2）功能障碍； 3）对冷压痛的敏感性。如果支持主要结果的假设，将检查涉及经前焦虑，易怒和总症状严重程度以及对时间疼痛程序的时间求和（索引中心疼痛处理）的次要结果指标。在实验室（干预之前和之后）中，将在静止和响应精神压力时评估预测的MBSR功效生物学介质：1）交感神经系统（血压，心率，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（等离子体IL-6）; 4）心脏自主神经控制（压力感受器反射灵敏度）。预测的心理治疗疗效是：1）特质正念； 2）接受； 3）反思，在干预之前，中点和之后进行评估。在进行8周干预之后，将遵循6个月的妇女来评估有益结果的可持续性。结果将是干预阶段：每日症状评分，功能和疼痛敏感性（在第3和第6个月进行了测试）以及依从性。