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Internet-delivered Postpartum Anxiety Prevention

Development and Pilot Test of Internet-delivered Postpartum Anxiety Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03563339
Acronym
PPOD
Enrollment
19
Registered
2018-06-20
Start date
2020-04-08
Completion date
2021-12-13
Last updated
2023-04-27

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

Conditions

Postpartum Disorder

Brief summary

Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. Up to 16% of mothers experience postpartum anxiety or related disorders, such as OCD. With respect to the investigator's own community, this means that up to 3,313 women in West Virginia may struggle with postpartum anxiety or OCD. Left untreated, perinatal anxiety and OCD are associated with numerous adverse outcomes, such as maternal depression, preterm birth, impaired fetal development, low birthweight, difficulty breastfeeding, anxiety in children, and interference with parent-infant bonding. Critically, anxiety is a risk factor for cardiovascular disease and substance use disorders, both significant West Virginia health disparities. Thus, there is a critical need to develop effective and scalable prevention programs to address postpartum anxiety and OCD. The purpose of this proposed community-engaged study is to develop and test the feasibility, usability, and acceptability of an Internet-delivered postpartum anxiety and OCD prevention program, called Preventing Postpartum Onset Distress, or P-POD.

Interventions

BEHAVIORALP-POD

. P-POD will include seven 30-minute online, educational, interactive modules that teach at-risk pregnant women skills derived from the gold standard, empirically supported cognitive-behavioral treatment for anxiety disorders and OCD. Additionally, P-POD will include three modules for fathers, to help them support their partners during the postpartum period. We will modify P-POD from an already existing in-person prevention program for postpartum OCD (developed by Co-Investigator Kiara Timpano). The m-health foundation of P-POD will be an already existing Internet-delivered treatment infrastructure (OurRelationship.com, developed by Co-Investigator Brian Doss).

Sponsors

West Virginia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

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

Inclusion criteria

* Female * Aged 18 or older * Pregnant with first child * Married or living with a partner * State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139

Exclusion criteria

* past or current anxiety disorders * past or current OCD * past or current psychotic disorders * past or current bipolar disorders * past or current substance use disorders.

Design outcomes

Primary

MeasureTime frameDescription
State-Trait Anxiety Inventory-Trait (STAI-Trait)Change from Baseline to Week 1020-item self-report used to assess dispositional levels of anxiety. It is widely used, sensitive to treatment, has strong psychometric properties, and includes items that would be relevant to pregnant women. The STAI-Trait Total Score will be used before and after P-POD to assess change in prenatal trait anxiety. The STAI-Trait total score ranges from 20 to 80. Higher numbers represent more anxiety (worse outcome).
Obsessive Beliefs Questionnaire (OBQ-44)Change from Baseline to Week 1044-item self-report scale used to measure dysfunctional beliefs associated with anxiety and OCD symptoms. The OBQ-44 has strong psychometric properties and has demonstrated sensitivity to treatment with pregnant women. In the proposed study, the OBQ-44 Total Score will be administered before and after P-POD to assess change in dysfunctional beliefs. The OBQ-44 total score ranges from 44 to 308. Higher numbers represent more dysfunctional OCD beliefs (worse outcome).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026