Internet-delivered Postpartum Anxiety Prevention

NCT ID: NCT03563339

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2021-12-13

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.

Conditions

Postpartum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

P-POD

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

Group Type: EXPERIMENTAL

P-POD

Intervention Type: BEHAVIORAL

. 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).

Interventions

P-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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Shari Steinman Haxel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Life Sciences Building

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

1710795361

Identifier Type: -

Identifier Source: org_study_id