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. We propose a clinical trial to adapt and test a brief, accessible intervention targeting misinterpretation of postpartum intrusive thoughts.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Intrusive Thoughts
• Intervention / Treatment: Behavioral: Postpartum Intrusive Thoughts and Anxiety (PITA) Program

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. We will pilot test the effectiveness of the intervention and examine its implementation outcomes by recruiting new parents (N = 30) in an open trial, aiming for a target of N = 24, accounting for attrition. We 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. We will evaluate 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martha J Falkenstein, PhD; Phone Number: 617-855-4424; Email: mfalkenstein@mclean.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postpartum Intrusive Thoughts and Anxiety (PITA) program; One-time psychoeducation intervention	Behavioral: Postpartum Intrusive Thoughts and Anxiety (PITA) Program; A single session intervention (15-30 minutes) of psychoeducational material about postpartum intrusive thoughts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscale	4-item subscale measuring severity of intrusive thoughts	Pre-intervention and 2-week follow-up

Collaborators and Investigators

• Sponsor: Mclean Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: postpartum; intrusive thoughts
• Other Study ID Numbers: 2025A011318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No