Division of Research, Kaiser Permanente Northern California, Pleasanton, CA, United States.
School of Medicine, University of California, Davis, Sacramento, CA, United States.
JMIR Res Protoc. 2024 Oct 29;13:e56882. doi: 10.2196/56882.
Postpartum depression (PPD) is associated with significant health consequences for the parent and child. Current recommendations for PPD prevention require intense health care system resources. Evidence-based interventions for PPD prevention that do not further burden the health care system are needed. Evidence suggests that physical activity (PA) can generally reduce depressive symptoms. Technology-based interventions may help decrease common barriers to PA.
This study aims to report the protocol and provide a data overview of the POstpartum Wellness study (POW)-an effectiveness trial evaluating whether an eHealth PA intervention tailored for postpartum individuals increased PA and decreased depressive symptoms among individuals at high PPD risk.
This remote parallel-group randomized controlled trial included postpartum individuals with a history of depression or at least moderate current depressive symptoms not meeting the PPD diagnostic threshold and with low PA levels from an integrated health care delivery system. Participants were randomized to an eHealth PA intervention or usual care. The intervention group received access to a library of web-based workout videos designed for postpartum individuals, which included interaction with their infants. At baseline and follow-up (3 and 6 months), PA was measured using questionnaires and a wrist-worn accelerometer. Depressive symptoms were measured using the Patient Health Questionnaire-8 (PHQ-8). Data were collected to assess exploratory outcomes of sleep, perceived stress, anxiety, parent-infant bonding, and infant development.
The study was funded in January 2020. Participants were enrolled via REDCap (Research Electronic Data Capture) or telephonically between November 2020 and September 2022; data collection ended in April 2023. Randomized participants (N=99) were 4 months post partum at baseline with moderately severe depressive symptoms (mean PHQ-8 score 12.6, SD 2.2). Intervention (n=50) and usual care (n=49) groups had similar sociodemographic characteristics, months post partum, baseline depressive symptoms, number of children at home, and prepregnancy PA levels. Retention in assessments was ≥66% for questionnaires and ≥48% for accelerometry, with modest differences by group. At 3-month follow-up, 73 of 99 (74%) participants (intervention: 35/50, 70%; usual care: 38/49, 78%) completed questionnaires; 53 of 99 (54%) wore the accelerometer for 7 days (27 of 50 (54%) intervention, 26 of 49 (53%) usual care). At 6-month follow-up, 66 of 99 (67%) participants (30 of 50 (60%) intervention, 36 of 49 (73%) usual care) completed questionnaires and 43 of 99 (43%) wore the accelerometer for 7 days (21 of 50 (42%) intervention, 22 of 49 (45%) usual care). Data analysis is completed, and a manuscript with these findings is currently under review for publication.
The POW trial evaluates the effectiveness of an eHealth PA intervention for improving depressive symptoms and increasing PA among postpartum individuals at high PPD risk. Results have implications for the design and delivery of behavioral interventions among vulnerable patients.
ClinicalTrials.gov NCT04414696; https://clinicaltrials.gov/ct2/show/NCT04414696.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56882.
产后抑郁症(PPD)会对父母和孩子的健康产生重大影响。目前预防 PPD 的建议需要大量的医疗保健系统资源。需要寻找预防 PPD 的基于证据的干预措施,而不会进一步加重医疗保健系统的负担。有证据表明,身体活动(PA)通常可以减轻抑郁症状。基于技术的干预措施可能有助于减少 PA 的常见障碍。
本研究旨在报告 POstpartum Wellness 研究(POW)的方案,并提供该研究的数据概述。这是一项评估针对产后个体的电子健康 PA 干预措施是否能增加 PA 并降低高 PPD 风险个体抑郁症状的有效性试验。
这是一项远程平行组随机对照试验,纳入了来自综合医疗服务系统的有抑郁史或当前至少有中度抑郁症状但不符合 PPD 诊断标准且 PA 水平较低的产后个体。参与者被随机分配到电子健康 PA 干预组或常规护理组。干预组可以访问为产后个体设计的网络锻炼视频库,其中包括与婴儿的互动。在基线和随访(3 个月和 6 个月)时,使用问卷和腕戴加速度计测量 PA。使用患者健康问卷-8(PHQ-8)测量抑郁症状。收集数据以评估睡眠、感知压力、焦虑、父母与婴儿的联系和婴儿发育等探索性结局。
该研究于 2020 年 1 月获得资金。参与者通过 REDCap(Research Electronic Data Capture)或电话于 2020 年 11 月至 2022 年 9 月期间入组;数据收集于 2023 年 4 月结束。随机参与者(N=99)在基线时产后 4 个月,有中度严重的抑郁症状(平均 PHQ-8 得分为 12.6,SD 2.2)。干预组(n=50)和常规护理组(n=49)的社会人口统计学特征、产后月数、基线抑郁症状、家中儿童人数和孕前 PA 水平相似。问卷调查的保留率≥66%,加速度计的保留率≥48%,但组间差异较小。在 3 个月的随访中,99 名参与者中有 73 名(74%)(干预组:35/50,70%;常规护理组:38/49,78%)完成了问卷调查;99 名参与者中有 53 名(54%)佩戴了加速度计 7 天(干预组 27/50(54%),常规护理组 26/49(53%))。在 6 个月的随访中,99 名参与者中有 66 名(67%)(干预组 30/50(60%),常规护理组 36/49(73%))完成了问卷调查,99 名参与者中有 43 名(43%)佩戴了加速度计 7 天(干预组 21/50(42%),常规护理组 22/49(45%))。数据分析已完成,目前正在对一篇包含这些发现的手稿进行审查,准备发表。
POW 试验评估了电子健康 PA 干预对提高高 PPD 风险产后个体抑郁症状和增加 PA 的有效性。结果对脆弱患者的行为干预的设计和提供具有启示意义。
ClinicalTrials.gov NCT04414696;https://clinicaltrials.gov/ct2/show/NCT04414696。
国际注册报告标识符(IRRID):DERR1-10.2196/56882。