Postpartum Intrusive ThoughtsNCT07725341
Single Session Intervention for Postpartum Intrusive Thoughts
A study testing Postpartum Intrusive Thoughts and Anxiety (PITA) Program in people with Postpartum Intrusive Thoughts, run by Mclean Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpartum Intrusive Thoughts
- What is being tested?
- Postpartum Intrusive Thoughts and Anxiety (PITA) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?"
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Postpartum Intrusive Thoughts
- Being tested
- Postpartum Intrusive Thoughts and Anxiety (PITA) Program
- Keywords
- intrusive thoughts, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Intrusive Thoughts and Anxiety (PITA) ProgramBehavioural
A single session intervention (15-30 minutes) of psychoeducational material about postpartum intrusive thoughts
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Intrusive Thoughts and Anxiety (PITA) program | Experimental | One-time psychoeducation intervention Receives: Behavioral: Postpartum Intrusive Thoughts and Anxiety (PITA) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscale
4-item subscale measuring severity of intrusive thoughts
Measured: Pre-intervention and 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Intrusive ThoughtsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha J Falkenstein, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725341
- Sponsor's protocol ID
- 2025A011318
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session Intervention for Postpartum Intrusive Thoughts
- ClinicalTrials.gov ID
- NCT07725341
- Acronym / sponsor ID
- 2025A011318
- Conditions
- Postpartum Intrusive Thoughts
- Keywords
- intrusive thoughts, postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Intrusive Thoughts and Anxiety (PITA) program | Experimental | Behavioral: Postpartum Intrusive Thoughts and Anxiety (PITA) ProgramOne-time psychoeducation intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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?"
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum Intrusive Thoughts and Anxiety (PITA) ProgramA single session intervention (15-30 minutes) of psychoeducational material about postpartum intrusive thoughts | Behavioural | Postpartum Intrusive Thoughts and Anxiety (PITA) program |
Primary outcome
Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscale
Time frame: Pre-intervention and 2-week follow-up
4-item subscale measuring severity of intrusive thoughts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Intrusive Thoughts and Anxiety (PITA) Program in people with Postpartum Intrusive Thoughts, run by Mclean Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha J Falkenstein, PhD (617-855-4424, mfalkenstein@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimensional Obsessive Compulsive Scale - Unacceptable Thoughts subscale (time frame: Pre-intervention and 2-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.