Internet-delivered Postpartum Anxiety Prevention

Not Applicable

Completed

• Conditions: Postpartum Disorder
• Interventions: Behavioral: P-POD

• Registration Number: NCT03563339
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Study Start: 2020-04-08
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P-POD	P-POD	All participants will complete the prevention for postpartum onset distress (P-POD)

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory-Trait (STAI-Trait)	Change from Baseline to Week 10	20-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 10	44-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).

Trial Locations

Locations (1)

Life Sciences Building; 🇺🇸 Morgantown, West Virginia, United States