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NCT Number: NCT07725341

Single Session Intervention for Postpartum Intrusive Thoughts

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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?"

Exclusion criteria

None

Treatment and study plan

Postpartum Intrusive Thoughts and Anxiety (PITA) Program

Behavioral

A single session intervention (15-30 minutes) of psychoeducational material about postpartum intrusive thoughts

Primary outcomes

  1. Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscale

    Time frame: Pre-intervention and 2-week follow-up

    4-item subscale measuring severity of intrusive thoughts

Study contacts

Contact information is provided by the study sponsor or research team.

Martha J Falkenstein, PhD

CONTACT

[email protected]

617-855-4424

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 24, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.