NCT07725341

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
37mo left

Started Oct 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

July 21, 2026

Last Update Submit

July 23, 2026

Conditions

Postpartum Intrusive Thoughts

Keywords

intrusive thoughtspostpartum

Outcome Measures

Primary Outcomes (1)

  • Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscale

    4-item subscale measuring severity of intrusive thoughts

    Pre-intervention and 2-week follow-up

Study Arms (1)

Postpartum Intrusive Thoughts and Anxiety (PITA) program

EXPERIMENTAL

One-time psychoeducation intervention

Behavioral: Postpartum Intrusive Thoughts and Anxiety (PITA) Program

Interventions

Postpartum Intrusive Thoughts and Anxiety (PITA) ProgramBEHAVIORAL

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

Postpartum Intrusive Thoughts and Anxiety (PITA) program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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?"

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Martha J Falkenstein, PhD

CONTACT

617-855-4424mfalkenstein@mclean.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Our clinical trial will be registered on clinicaltrials.gov and data for all research subjects will be submitted to the NIMH National Data Archive (NDA) using the data dictionaries available in NDA.