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临床试验/NCT07071025
NCT07071025尚未招募不适用

Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention

West Virginia University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)

研究概览

简要总结

Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. The purpose of this study is to evaluate the Internet-delivered postpartum anxiety and obsessive-compulsive disorder (OCD) prevention program, called "Preventing Postpartum Onset Distress", or P-POD. The overarching goal of this study is to conduct a randomized control trial of P-POD, an online program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia. Investigators will test the effects of P-POD compared to an anxiety education control intervention on risk factors for perinatal anxiety and assess mothers' anxiety symptoms, relationships with their partners, and relationships with their infants at 8-weeks postpartum. Eligible women and their partners will be consented at the start of the second trimester of pregnancy. Couples will be randomized into either the P-POD (active) or ANX-ED (control) intervention. Couples will then begin to work through the ten intervention modules: seven modules for women, at a recommended rate of one per week, and three modules for partners, at a recommended rate of no more than one per week. Women will complete brief weekly phone "coaching calls" to encourage module completion, ensure understanding of material, and answer any content-related or technical questions. Ten weeks after the pre-intervention assessment, women will complete the post-intervention assessment (same measures as pre-assessment).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pregnant and entering second trimester
  • •In a romantic relationship
  • •Partner must be agreeable to participate
  • •State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139

排除标准

  • •Must speak English

研究组 & 干预措施

Preventing Postpartum Onset Distress (P-POD)

Experimental

P-POD is an online self-guided program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia.

干预措施: Preventing Postpartum Onset Distress (P-POD) (Behavioral)

Anxiety Education (ANX-ED)

Placebo Comparator

ANX-ED will be adapted from an already-established in-person anxiety education control condition and will be modified to an Internet-based, self-guided program that serves as an attention control to P-POD.

干预措施: Anxiety Education (ANX-ED) (Behavioral)

结局指标

主要结局

Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)

时间窗: Change from Baseline to Week 10

Change in STAI-Trait score. This is a 20-item self-report used to assess dispositional levels of anxiety. It is widely used, sensitive to treatment, has strong psychometric properties, and includes items that would be relevant to pregnant women. The STAI-Trait Total Score will be used before and after P-POD to assess change in prenatal trait anxiety. The STAI-Trait total score ranges from 20 to 80. Higher numbers represent more anxiety (worse outcome).

Change in Obsessive Beliefs Questionnaire (OBQ)

时间窗: Change from Baseline to Week 10

Change in Obsessive Beliefs Questionnaire (OBQ) score. This measure assesses dysfunctional beliefs related to OCD in 44 items on a 7-point Likert-type scale, with items summed; higher scores indicate more dysfunctional beliefs. The OBQ has strong psychometric properties and has demonstrated sensitivity to treatment with pregnant women.

次要结局

  • Change in Perinatal Interpretations Questionnaire (PIQ)(Change from Baseline to Week 10)
  • Change in Social Provisions Checklist (SPC)(Change from Baseline to 8-weeks postpartum)
  • Overall Anxiety Severity and Impairment Scale (OASIS)(8-weeks postpartum)
  • Dimensional Obsessive-Compulsive Scale (DOCS)(8-weeks postpartum)
  • Edinburgh Postpartum Depression Scale (EPDS)(8-weeks postpartum)
  • Couple Satisfaction Index-4 (CSI-4)(8-weeks postpartum)
  • Postpartum Bonding Questionnaire (PBQ)(8-weeks postpartum)
  • Five Minute Speech Sample (FMSS)(8-weeks postpartum)
  • Qualitative Interview(8-weeks postpartum)

研究者

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

Michelle Roley-Roberts

Assistant Professor

West Virginia University

研究点 (1)

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