Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preventing Postpartum Onset Distress (P-POD), Anxiety Education (ANX-ED).
- Who it may be relevant to
- Registry conditions: Postpartum Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Behavioral 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 - 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, a
Primary outcome measures
- Change in State-Trait Anxiety Inventory-Trait (STAI-Trait) [Time frame: Change from Baseline to Week 10]
- Change in Obsessive Beliefs Questionnaire (OBQ) [Time frame: Change from Baseline to Week 10]
Secondary outcome measures (9)
- Change in Perinatal Interpretations Questionnaire (PIQ) [Time frame: Change from Baseline to Week 10]
- Change in Social Provisions Checklist (SPC) [Time frame: Change from Baseline to 8-weeks postpartum]
- Overall Anxiety Severity and Impairment Scale (OASIS) [Time frame: 8-weeks postpartum]
- Dimensional Obsessive-Compulsive Scale (DOCS) [Time frame: 8-weeks postpartum]
- Edinburgh Postpartum Depression Scale (EPDS) [Time frame: 8-weeks postpartum]
- Couple Satisfaction Index-4 (CSI-4) [Time frame: 8-weeks postpartum]
- Postpartum Bonding Questionnaire (PBQ) [Time frame: 8-weeks postpartum]
- Five Minute Speech Sample (FMSS) [Time frame: 8-weeks postpartum]
- Qualitative Interview [Time frame: 8-weeks postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Life Sciences Building — Morgantown
Identifiers
NCT: NCT07071025 · 2210663965 · R15HD109689