Single Session Intervention for Postpartum Intrusive Thoughts

Обзор

Despite their impact, postpartum intrusive thoughts- unwanted, distressing thoughts, images, and urges often about harming one's infant, are common yet overlooked. This can lead to distress, shame, impairment, and for some, diagnoses of depression, anxiety, or OCD. This project aims to adapt and test a brief, accessible intervention targeting misinterpretation of postpartum intrusive thoughts.

Подробное описание

This proposal aims to adapt and refine two evidence-based interventions into a scalable, personalized, digital intervention targeting the misinterpretation of intrusive thoughts during the postpartum period. The intervention will be piloted for its effectiveness, and its implementation outcomes will be examined by recruiting new parents (N = 30) in an open trial, aiming for a target of N = 24, accounting for attrition. This study will recruit across the U.S. from the leading digital resource for new and expectant parents with a nationally representative user population, and will facilitate its reach to people with distressing intrusive thoughts regardless of where they live - rural, suburban, or urban areas. Outcomes to be evaluated include: target engagement (interpretation bias), changes in our primary outcome (intrusive thoughts severity), and feasibility and acceptability (see Measures).

In this pilot trial, our central hypothesis is the intervention will be feasible, acceptable, and meet a priori benchmarks for preliminary effectiveness in reducing interpretation bias and improving outcomes for clinical levels of postpartum intrusive thoughts, parent anxiety, and psychosocial functioning. Testing effectiveness and implementation will inform strategies to refine and integrate low-burden digital interventions for new parents into real-world service delivery, supporting a fully-powered hybrid type 1 trial and enabling dissemination of a brief, accessible, low-cost intervention to reduce the perinatal intrusive thoughts and improve public health for new parents.

Вмешательства

• Поведенческое Postpartum Intrusive Thoughts and Anxiety (PITA) Program
  A single session intervention (15-30 minutes) of psychoeducational material about postpartum intrusive thoughts

Первичные конечные точки

• Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscale [Срок оценки: Pre-intervention and 2-week follow-up]

Критерии участия

Критерии включения

• age 18 or older
• fluent in English, per self-report
• became a parent of an infant in the past 3 months (biological, adoptive, or caregiving parent)
• elevated interpretation bias (score of >131 on Obsessive Beliefs Questionnaire-44 (OBQ-44; 1 SD above mean of non-clinical sample)
• endorse, "In the past week, have you had images pop into your head that you didn't want, like violent or horrible scenes or something of a sexual nature?" or "how about having urges to do something that kept coming back to you even though you didn't want them to, like an urge to harm a loved one?"

Критерии исключения

None

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07725341 · 2025A011318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗