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Single Session Intervention for Postpartum Intrusive Thoughts

Single Session Intervention for Postpartum Intrusive Thoughts

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07725341
Enrollment
30
Registered
2026-07-24
Start date
2026-10-01
Completion date
2029-09-30
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Intrusive Thoughts

Keywords

intrusive thoughts, postpartum

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPostpartum Intrusive Thoughts and Anxiety (PITA) Program

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

Sponsors

Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. age 18 or older 2. fluent in English, per self-report 3. became a parent of an infant in the past 3 months (biological, adoptive, or caregiving parent) 4. elevated interpretation bias (score of \>131 on Obsessive Beliefs Questionnaire-44 (OBQ-44; 1 SD above mean of non-clinical sample) 5. 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

Design outcomes

Primary

MeasureTime frameDescription
Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscalePre-intervention and 2-week follow-up4-item subscale measuring severity of intrusive thoughts

Contacts

CONTACTMartha J Falkenstein, PhD
mfalkenstein@mclean.harvard.edu617-855-4424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026