Postpartum Intrusive Thoughts and Anxiety (PITA) Program
BehavioralA single session intervention (15-30 minutes) of psychoeducational material about postpartum intrusive thoughts
NCT Number: NCT07725341
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None
A single session intervention (15-30 minutes) of psychoeducational material about postpartum intrusive thoughts
Time frame: Pre-intervention and 2-week follow-up
4-item subscale measuring severity of intrusive thoughts
Contact information is provided by the study sponsor or research team.
Mclean Hospital
Other
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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.