Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention

Обзор

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).

Вмешательства

• Поведенческое Preventing Postpartum Onset Distress (P-POD)
  P-POD contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules are designed to educate pregnant women about perinatal anxiety (psychoeducation), teach women to change their thinking patterns (cognitive restructuring), and guide women through testing their dysfunctional beliefs and fears (behavioral experiments). Each of these modules engage the pregnant woman in various self-guided exercises to consolidate the lessons learned. In addition
• Поведенческое Anxiety Education (ANX-ED)
  ANX-ED educates women and their partners about seven anxiety and related disorders. ANX-ED contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules and three partner-directed modules will educate participants about generalized anxiety disorder, social anxiety disorder, panic disorder, specific phobia, obsessive-compulsive disorder, and posttraumatic stress disorder. Specifically, modules will include the diagnostic criteria, prevalence, a

Первичные конечные точки

• Change in State-Trait Anxiety Inventory-Trait (STAI-Trait) [Срок оценки: Change from Baseline to Week 10]
• Change in Obsessive Beliefs Questionnaire (OBQ) [Срок оценки: Change from Baseline to Week 10]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

-Must speak English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Life Sciences Building — Morgantown

Идентификаторы

NCT: NCT07071025 · 2210663965 · R15HD109689

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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