Internet-delivered Postpartum Anxiety Prevention (PPOD)
Primary Purpose
Postpartum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P-POD
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Disorder
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.
Sites / Locations
- Life Sciences Building
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
P-POD
Arm Description
All participants will complete the prevention for postpartum onset distress (P-POD)
Outcomes
Primary Outcome Measures
State-Trait Anxiety Inventory-Trait (STAI-Trait)
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)
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03563339
Brief Title
Internet-delivered Postpartum Anxiety Prevention
Acronym
PPOD
Official Title
Development and Pilot Test of Internet-delivered Postpartum Anxiety Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P-POD
Arm Type
Experimental
Arm Description
All participants will complete the prevention for postpartum onset distress (P-POD)
Intervention Type
Behavioral
Intervention Name(s)
P-POD
Intervention Description
. 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).
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory-Trait (STAI-Trait)
Description
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).
Time Frame
Change from Baseline to Week 10
Title
Obsessive Beliefs Questionnaire (OBQ-44)
Description
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).
Time Frame
Change from Baseline to Week 10
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Life Sciences Building
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Internet-delivered Postpartum Anxiety Prevention
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