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Not Yet RecruitingNCT07071025

Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
West Virginia University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. The purpose of this study is to evaluate the Internet-delivered postpartum anxiety and obsessive-compulsive disorder (OCD) prevention program, called "Preventing Postpartum Onset Distress", or P-POD. The overarching goal of this study is to conduct a randomized control trial of P-POD, an online program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia. Investigators will test the effects of P-POD compared to an anxiety education control intervention on risk factors for perinatal anxiety and assess mothers' anxiety symptoms, relationships with their partners, and relationships with their infants at 8-weeks postpartum. Eligible women and their partners will be consented at the start of the second trimester of pregnancy. Couples will be randomized into either the P-POD (active) or ANX-ED (control) intervention. Couples will then begin to work through the ten intervention modules: seven modules for women, at a recommended rate of one per week, and three modules for partners, at a recommended rate of no more than one per week. Women will complete brief weekly phone "coaching calls" to encourage module completion, ensure understanding of material, and answer any content-related or technical questions. Ten weeks after the pre-intervention assessment, women will complete the post-intervention assessment (same measures as pre-assessment).

Conditions

Interventions

TypeNameDescription
BEHAVIORALPreventing Postpartum Onset Distress (P-POD)P-POD contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules are designed to educate pregnant women about perinatal anxiety (psychoeducation), teach women to change their thinking patterns (cognitive restructuring), and guide women through testing their dysfunctional beliefs and fears (behavioral experiments). Each of these modules engage the pregnant woman in various self-guided exercises to consolidate the lessons learned. In addition, three partner-directed modules are designed to educate partners about perinatal anxiety, coach partners on providing emotional and social supports to pregnant women at risk for perinatal anxiety, and prepare partners for developmentally normative changes in their relationships following birth. Modules are designed to be completed weekly during the second trimester.
BEHAVIORALAnxiety Education (ANX-ED)ANX-ED educates women and their partners about seven anxiety and related disorders. ANX-ED contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules and three partner-directed modules will educate participants about generalized anxiety disorder, social anxiety disorder, panic disorder, specific phobia, obsessive-compulsive disorder, and posttraumatic stress disorder. Specifically, modules will include the diagnostic criteria, prevalence, and etiology of the disorders. They will also include animated examples of mothers experiencing the disorders described in each module. Each module engages the pregnant woman (or partner) in various self-guided exercises to consolidate the material learned.

Timeline

Start date
2025-08-01
Primary completion
2027-05-01
Completion
2027-12-01
First posted
2025-07-17
Last updated
2025-07-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07071025. Inclusion in this directory is not an endorsement.