Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention

Conditions

• Postpartum Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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).

Key Dates

Start date

Aug 31, 2025

Status verified

Jul 2025

Primary completion

May 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: 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.
• Placebo Comparator: 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.

Primary Outcome Measure

Change in State-Trait Anxiety Inventory-Trait (STAI-Trait) [ Time Frame: Change from Baseline to Week 10 ]

Central Contacts

• Michelle Roley Roberts, PhD
  (304) 293-2001
  [email protected]
• Shari Steinman, PhD
  3042931662
  [email protected]

Locations (1)

Find similar trials in Morgantown, WV

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