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临床试验/NCT05196152
NCT05196152进行中(未招募)不适用

MomMoodBooster Randomized Components Trial: A Program for Perinatal Depressed Female Veterans

University of Iowa2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Change in Behavioral Activation

研究概览

简要总结

The MomMoodBooster intervention is an empirically validated treatment for postpartum depression symptoms. The intervention was created by Brian Danaher and Milagra Tyler, who have continued to update the intervention technology and content. The intervention is now available for pregnant and postpartum Veterans, and it is accessible on browsers via computer, tablet, or mobile phone. The intervention contains six cognitive-behavioral modules that span six weeks, and it includes identification of pleasant activities, tracking mood and thoughts, and identification of goals. The current trial is an expansion of a nationwide service delivery project that has been ongoing for six years with the goal of offering the intervention to postpartum Veterans nationwide. Within that study, Veterans completed the online modules in concert with weekly phone coaching calls wherein coaches applied the content to the Veteran's current life. In addition, two booster modules and associated coaching calls were developed to continue application of the skills beyond the six-week intervention period. The present study seeks to investigate the incremental utility of the phone coaching component of the intervention by randomizing pregnant and postpartum Veterans to the MomMoodBooster intervention or the MomMoodBooster intervention plus phone coaching. Primary outcomes will include depressive symptoms, behavioral activation, and negative automatic thoughts.

详细描述

The purpose of the current study is to: 1) expand the MomMoodBooster intervention to pregnant Veterans and 2) to randomize Veterans to one of two intervention conditions. Veterans may be randomized to either 1) MomMoodBooster online intervention only or 2) MomMoodBooster online intervention and phone coaching. The study will examine the incremental utility of the phone coaching component of the intervention with the ultimate goal of VA-wide implementation. Veterans who report a history of or current mania or psychosis will be referred to mental health care locally. Patients who report elevated suicide risk will be directed to go to the nearest emergency room.

The study will recruit Veterans from around the nation. Investigators expect that 20% of female Veterans may be eligible. Based on national data, approximately 152,046 female Veterans in the USA are likely to have received care at a VA facility and are within the eligible age range. Centers for Disease Control and Prevention (CDC) data indicate that birth rates per 1000 women is 12.7. As such, about 3,866 female Veterans may be eligible per year. Veterans are eligible throughout the duration of pregnancy and up to 26 weeks postpartum.

Use of the medical record has proved successful in screening and enrolling postpartum Veterans nationwide. Veterans who are noted to be pregnant or postpartum in the VA medical record will be contacted to determine interest and eligibility.

Data will be obtained from the Veterans Health Administration (VHA) Corporate Data Warehouse through the VA Informatics and Computing Infrastructure, which includes pregnancy and postpartum diagnoses by the International Classification of Disease Tenth Revision Clinical Modification (ICD-9 and ICD-10 CM) codes, VHA outpatient visit dates, community care consults and medical services, patient demographics (such as race, ethnicity, date of birth, patient mailing address, and Rural-Urban Commuting Area Codes), and contact information. These data will be stored in a Microsoft Access database on VA servers, and the database will only be accessible to select members of the research team. The data will be imported to Access by a VA employee who does not have access to any participant data following enrollment. Demographic data are expected to be complete due to data being extracted from electronic medical records. All obstetric information will be verified in the screening process to ensure updated information is considered. Oversampling for rural Veterans will be conducted with the hopes of enrolling more rural Veterans (2:1 rural:non-rural Veteran ratio).

Veterans may also be referred through Maternity Care Coordinators (MCCs) or providers at VA medical centers. The MCCs may provide Veterans with the study's contact information or call the study team directly with the Veteran's permission. Veterans may also self-refer to the program by calling the research team or expressing interest via the MomMoodBooster website through the Contact link.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Currently pregnant or within 26 weeks postpartum
  • 18 - 50 years of age
  • Experiencing elevated depressive symptoms at screening (PHQ-9 score of 10 or more)
  • Have access to internet or smartphone

排除标准

  • Past or current mania
  • Current hypomania
  • Past or current psychoses
  • Active suicidality

结局指标

主要结局

Change in Behavioral Activation

时间窗: Through study completion, an average of 6 months

The Behavioral Activation for Depression Scale, short form (BADS), assesses engagement with valued life domains. The scale has four subscales, including activation, avoidance/rumination, work/school impairment, and social impairment. The 25 items are rated on a 0-6 Likert scale, and items from the avoidance, work/school, and social subscales are reverse-scored. Total scores range from 0-150, with higher scores indicating higher engagement with personal values.

Change in Negative Automatic Thoughts

时间窗: Through study completion, an average of 6 months

This measure assesses the frequency of negative automatic thoughts. The 15 items are rated on a 1-4 Likert scale. Total scores range from 15-60, with higher scores indicating more frequent negative automatic thoughts.

Change in Depressive Symptoms

时间窗: Through study completion, an average of 6 months

Symptoms of dysphoria, anhedonia, avolition, suicidality, lassitude, and changes in sleep and appetite are measured. The measure being utilized is the Inventory of Depression and Anxiety Symptoms, version 2 (IDAS-II). The 99 items are rated on a 5-point Likert scale from Not At All to Extremely. The measure of depressive symptoms used for this outcome is a 20-item composite, General Depression, and higher scores represent higher levels of depressive symptoms. Scores range from 20-100.

次要结局

  • Change in Dyadic Adjustment(Through study completion, an average of 6 months)
  • Change in Anxiety Symptoms(Through study completion, an average of 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Thomas

Clinical Assistant Professor

University of Iowa

研究点 (2)

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