Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention

NCT07071025 | Not Yet Recruiting DMC

• 2 other identifiers: 2210663965R15HD109689
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)

  Change in STAI-Trait score. This is a 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).

  Change from Baseline to Week 10

• Change in Obsessive Beliefs Questionnaire (OBQ)

  Change in Obsessive Beliefs Questionnaire (OBQ) score. This measure assesses dysfunctional beliefs related to OCD in 44 items on a 7-point Likert-type scale, with items summed; higher scores indicate more dysfunctional beliefs. The OBQ has strong psychometric properties and has demonstrated sensitivity to treatment with pregnant women.

  Change from Baseline to Week 10

Secondary Outcomes (9)

• Change in Perinatal Interpretations Questionnaire (PIQ)

  Change from Baseline to Week 10

• Change in Social Provisions Checklist (SPC)

  Change from Baseline to 8-weeks postpartum

• Overall Anxiety Severity and Impairment Scale (OASIS)

  8-weeks postpartum

• Dimensional Obsessive-Compulsive Scale (DOCS)

  8-weeks postpartum

• Edinburgh Postpartum Depression Scale (EPDS)

  8-weeks postpartum

Study Arms (2)

Preventing Postpartum Onset Distress (P-POD)

EXPERIMENTAL

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

Behavioral: Preventing Postpartum Onset Distress (P-POD)

Anxiety Education (ANX-ED)

PLACEBO COMPARATOR

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.

Behavioral: Anxiety Education (ANX-ED)

Interventions

Preventing Postpartum Onset Distress (P-POD) 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.

Preventing Postpartum Onset Distress (P-POD)

Anxiety Education (ANX-ED) 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.

Anxiety Education (ANX-ED)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant individuals
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Must speak English

Sponsors & Collaborators

• West Virginia University: lead
• University of Vermont: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Life Sciences Building

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Puerperal Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michelle Roley Roberts, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Roley Roberts, PhD

CONTACT

(304) 293-2001; michelle.roleyroberts@mail.wvu.edu

Shari Steinman, PhD

CONTACT

3042931662; shari.steinman@mail.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)