Personalized Integrated Chronotherapy for Perinatal Depression

围产期抑郁症的个性化综合计时疗法

基本信息

批准号：
10523528
负责人：
Katherine M Sharkey
金额：
$ 123.06万
依托单位：
RHODE ISLAND HOSPITAL
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：
2020-02-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10523528
关键词：
Acceleration Address Adverse event Affect Ambulatory Care Ankle Antidepressive Agents Anxiety Anxiety Disorders Beds Behavior Blinded Breast Feeding Child Chronobiology Chronotherapy Circadian Dysregulation Circadian Rhythms Clinical Collaborations DSM-V Data Dedications Depressive disorder Diagnosis Disease Enrollment Evaluation Expectancy Face Functional disorder Future Goals Hamilton Rating Scale for Depression Health Health Personnel High Prevalence Hospitals Human Anti-Mouse Antibody Human Milk Infant Intervention Interview Light Link Major Depressive Disorder Measures Mediating Mediation Melatonin Mental Depression Mental disorders Monitor Mood Disorders Moods Morbidity - disease rate Mothers National Institute of Mental Health Nonpharmacologic Therapy North Carolina Outcome Outpatients Participant Patient Care Patient Self-Report Patients Perinatal Pharmaceutical Preparations Phase Phototherapy Postpartum Depression Postpartum Period Postpartum Women Pregnancy Pregnancy Trimesters Pregnant Women Process Productivity Psychiatric therapeutic procedure Psychotherapy Public Health Randomized Recovery Reporting Research Domain Criteria Rhode Island Risk Risk Factors Role Safety Salivary Sample Size Site Sleep Strategic Planning Structure Suicide Targeted Research Testing Third Pregnancy Trimester Time Treatment outcome Universities Visit Woman Work Wrist actigraphy animal data antepartum depression anxiety symptoms biobehavior care seeking circadian clinical care clinical practice comorbidity confirmatory clinical trial depressive symptoms economic cost effective therapy efficacious treatment efficacy evaluation efficacy testing experience health care service utilization human data improved individual patient innovation intergenerational mood symptom mortality novel offspring participant enrollment perinatal period perinatal women peripartum depression personalized approach pregnant recruit response side effect sleep behavior sleep onset sleep pattern stem treatment as usual

项目摘要

Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non- pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient’s individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self- report. The safety profile of the PIC intervention will be assessed by evaluation of side effects/adverse events. Importantly, the study will also examine the target mechanisms by which PIC is hypothesized to work and test the mediation effects of the circadian targets on improvement in mood symptoms. Participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and to estimate sleep timing and duration. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (~30 weeks’ gestation), at 36 weeks’ gestation, and at postpartum week 6. Exploratory aims will examine associations between infant sleep behavior and maternal circadian rhythms and factors relevant to future dissemination of PIC. If this intervention is effective, perinatal PIC could change clinical practice and have major public health impact due to the high prevalence of perinatal depression and anxiety, the negative effects of mood disorders on mothers and their children, and the need to provide effective, novel, non-pharmacologic therapies for women with perinatal mood disorders.

围产期抑郁和焦虑是常见、严重且经常重叠的疾病，会增加新妈妈的发病率和死亡率（包括自杀）并导致婴儿/儿童结局不佳。治疗常常无法恢复或耐受性差，许多孕妇寻求非治疗当非药物治疗不可用时，药物治疗或放弃治疗。经历昼夜节律失调的新妈妈患围产期抑郁症的风险增加。这项针对精神障碍的非药物干预措施的验证功效临床试验 R01 寻求测试个性化综合时间疗法 (PIC) 干预是否可以改善治疗结果对于寻求抑郁症门诊治疗（无论是否伴有焦虑）的怀孕患者来说，PIC 都是一种选择。多成分治疗，包括强光治疗、睡眠阶段提前和睡眠稳定/限制，针对昼夜节律和睡眠-觉醒行为的研究领域标准 (RDoC) 结构，为了增加样本量和多样性并加速招募，本研究将进行。在临床结构不同且已试点 PIC 干预的 4 个地点进行该研究将招募在妊娠第三个月期间被诊断患有重度抑郁症的孕妇。 (a) 常规护理 (UC, n = 110) 或 (b) PIC+UC (n = 110) 会怀孕和产后。 PIC 将根据每个患者的个人昼夜节律和睡眠时间，通过定制的个性化方法进行管理，以优化干预措施。专门的临床就诊：妊娠第三个月期间进行 3 次，产后期间进行 2 次。将对两组的药物和/或心理治疗进行量化，以评估两组之间的差异。 PIC+UC 和 UC 组的情绪将通过盲法临床医生访谈和患者自我评估进行测量。 PIC 干预的安全性将通过副作用/不良事件的评估来评估。重要的是，该研究还将研究 PIC 发挥作用和测试的目标机制昼夜节律目标对情绪症状改善的中介作用参与者将佩戴手腕。在怀孕第 28-40 周和产后第 2-6 周连续进行体动记录仪/光监测以进行评估光暴露并估计睡眠时间和持续时间（用唾液微弱光测量）。褪黑激素开始）将在怀孕期间（约妊娠 30 周）、妊娠 36 周时在基线进行测量，以及产后第 6 周。探索性目标将检查婴儿睡眠行为与母亲的昼夜节律和与未来 PIC 传播相关的因素如果这种干预措施有效，由于围产期 PIC 的高患病率，可能会改变临床实践并对公共卫生产生重大影响围产期抑郁和焦虑、情绪障碍对母亲及其孩子的负面影响，以及需要为患有围产期情绪障碍的妇女提供有效、新颖、非药物疗法。

项目成果

期刊论文数量（9）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Poor neonatal adaptation syndrome: Toward a clinical consensus to guide research and counseling.

新生儿适应不良综合征：达成临床共识以指导研究和咨询。

DOI：
10.1111/acps.13386
发表时间：
2022
期刊：
Acta psychiatrica Scandinavica
影响因子：
6.7
作者：
Carlini,SaraV;Deligiannidis,KristinaM
通讯作者：
Deligiannidis,KristinaM

Associations between Perinatal Sleepiness and Breastfeeding Intentions and Attitudes and Infant Feeding Behaviors and Beliefs.

DOI：
10.3390/nu15153435
发表时间：
2023-08-03
期刊：
NUTRIENTS
影响因子：
5.9
作者：
von Ash, Tayla;Alikhani, Anna;Sharkey, Katherine M.;Solano, Paola;Aquino, Melanie Morales;Risica, Patricia Markham
通讯作者：
Risica, Patricia Markham

Successful lactation after resuming methylphenidate in a woman with narcolepsy.

患有发作性睡病的女性恢复哌醋甲酯后成功哺乳。

DOI：
10.5664/jcsm.10018
发表时间：
2022
期刊：
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
影响因子：
0
作者：
Bello,Gisel;Poirier,Jessica;Sharkey,KatherineM
通讯作者：
Sharkey,KatherineM

Antenatal Antidepressant Prescription Associated With Reduced Fetal Femur Length but Not Estimated Fetal Weight: A Retrospective Ultrasonographic Study.