Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention

NCT ID: NCT07071025

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-12-31

Brief 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

Postpartum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Preventing Postpartum Onset Distress (P-POD)

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

Group Type: EXPERIMENTAL

Preventing Postpartum Onset Distress (P-POD)

Intervention Type: BEHAVIORAL

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.

Anxiety Education (ANX-ED)

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.

Group Type: PLACEBO_COMPARATOR

Anxiety Education (ANX-ED)

Intervention Type: BEHAVIORAL

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.

Interventions

Preventing 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.

Intervention Type: BEHAVIORAL

Anxiety 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Michelle Roley-Roberts

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Roley Roberts, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

Life Sciences Building

Morgantown, West Virginia, United States

Countries

United States

Central Contacts

Michelle Roley Roberts, PhD

Role: CONTACT

michelle.roleyroberts@mail.wvu.edu

(304) 293-2001

Shari Steinman, PhD

Role: CONTACT

shari.steinman@mail.wvu.edu

3042931662

Facility Contacts

Shari A Steinman, PhD

Role: primary

michelle.roleyroberts@mail.wvu.edu

(304) 293-2001

Other Identifiers

R15HD109689

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2210663965

Identifier Type: -

Identifier Source: org_study_id