Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention (P-POD)

West Virginia University

Status: Not yet enrolling

Conditions: Postpartum Disorder

Treatments: Behavioral: Preventing Postpartum Onset Distress (P-POD); Behavioral: Anxiety Education (ANX-ED)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07071025

R15HD109689 (U.S. NIH Grant/Contract)

2210663965

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant and entering second trimester
• In a romantic relationship
• Partner must be agreeable to participate
• State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139

Exclusion criteria

-Must speak English

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Preventing Postpartum Onset Distress (P-POD)

Experimental group

Description:

P-POD is an online self-guided program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia.

Treatment:

Behavioral: Preventing Postpartum Onset Distress (P-POD)

Anxiety Education (ANX-ED)

Placebo Comparator group

Description:

ANX-ED will be adapted from an already-established in-person anxiety education control condition and will be modified to an Internet-based, self-guided program that serves as an attention control to P-POD.

Treatment:

Behavioral: Anxiety Education (ANX-ED)