- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03563339
Internet-delivered Postpartum Anxiety Prevention (PPOD)
April 26, 2023 updated by: Shari Steinman Haxel, West Virginia University
Development and Pilot Test of Internet-delivered Postpartum Anxiety Prevention
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shari A Steinman, PhD
- Phone Number: 3042931662
- Email: shari.steinman@mail.wvu.edu
Study Locations
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West Virginia
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Morgantown, West Virginia, United States, 26506
- Life Sciences Building
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: P-POD
All participants will complete the prevention for postpartum onset distress (P-POD)
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. 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State-Trait Anxiety Inventory-Trait (STAI-Trait)
Time Frame: 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).
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Change from Baseline to Week 10
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Obsessive Beliefs Questionnaire (OBQ-44)
Time Frame: 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).
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Change from Baseline to Week 10
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 8, 2020
Primary Completion (Actual)
December 13, 2021
Study Completion (Actual)
December 13, 2021
Study Registration Dates
First Submitted
May 29, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1710795361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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