An interventional study of P-POD in Postpartum Disorder, sponsored by West Virginia University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by West Virginia University · Not applicable, Interventional, and 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.
40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.
This study's enrollment of 19 is below the median of 81 across 32 interventional studies indexed under Puerperal Disorders.
Browse Puerperal Disorders studies →West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Exclusion Criteria:
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).
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).
Time frame: Change from Baseline to Week 10
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).
Time frame: Change from Baseline to Week 10
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Apr 2020 to primary completion in Dec 2021, 20 months.
Of 20 interventional studies with no phase under Puerperal Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 20 months is close to that.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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