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的，严重的，并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），导致婴儿/儿童结局不佳。当前的疗法通常无法产生恢复或耐受性不佳，许多孕妇寻求非 - 当没有药物治疗时，没有药物治疗或忘记治疗。期待和经历昼夜节律失调的新母亲的围产期抑郁症风险增加。对精神疾病的非药物干预措施R01的这项确认性疗效临床试验寻求测试个性化的综合年代疗法（PIC）干预是否可以改善治疗结果对于寻求门诊治疗抑郁症的孕妇患者，或者有焦虑症。图片是由明亮的光治疗，睡眠期前进和睡眠稳定/限制组成的多组分处理，该治疗针对昼夜节律和睡眠效果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，这项研究将在临床结构不同并试图进行PIC干预的4个地点进行。这项研究将招募预期母亲在怀孕第三个三个月期间被诊断出患有重度抑郁症的母亲。我们将随机将患者随机进行：（a）通常的护理（UC，n = 110）或（b）pic+uc（n = 110）。 PIC+UC将怀孕和产后组件，将通过量身定制的个性化方法来管理，以根据每个患者的昼夜节律和睡眠时间来优化干预措施。基线评估后，将在5期间开处方专用的临床就诊：三个月三个月的三个，产后2个。 UC将组成药物和/或心理疗法。 UC将在两组中进行量化，以评估 PIC+UC和UC组。两组将通过盲目的临床访谈和患者自我来衡量情绪报告。 PIC干预的安全性将通过评估副作用/不良事件来评估。重要的是，该研究还将检查假设PIC进行工作和测试的目标机制昼夜节律目标对改善情绪症状的调解作用。参与者会戴手腕行为图/轻型监视器在怀孕和产后2-6周期间连续28-40周进行评估轻曝光并估计睡眠时间和持续时间。昼夜节相（用唾液昏暗的光测量褪黑激素的发作将在怀孕期间基线（妊娠30周）时测量，妊娠36周，在产后第6周。探索目的将检查婴儿睡眠行为与母亲的昼夜节律和与未来的图片传播有关的因素。如果此干预有效，围产期图片可能会改变临床实践，并由于高度的公共卫生影响很大围产期抑郁和焦虑，情绪障碍对母亲及其子女的负面影响，以及需要为患有围产期情绪障碍的女性提供有效的，新颖的非药物疗法。

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.