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Internet-delivered Postpartum Anxiety Prevention (PPOD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563339
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Shari Steinman Haxel, West Virginia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postpartum Disorder Behavioral: P-POD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development and Pilot Test of Internet-delivered Postpartum Anxiety Prevention
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: P-POD
All participants will complete the prevention for postpartum onset distress (P-POD)
 Behavioral: 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563339


Contacts
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Contact: Shari A Steinman, PhD 3042931662 shari.steinman@mail.wvu.edu

Locations
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United States, West Virginia
Life Sciences Building Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Shari A Steinman, PhD    304-293-1662    ppodwvu@gmail.com   
Sponsors and Collaborators
West Virginia University
More Information
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Responsible Party: Shari Steinman Haxel, Assistant Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03563339    
Other Study ID Numbers: WVCTSI PPOD
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Puerperal Disorders
Pregnancy Complications