Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- West Virginia University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)
Time Frame: Change from Baseline to Week 10
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 in Obsessive Beliefs Questionnaire (OBQ)
Time Frame: Change from Baseline to Week 10
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.
Secondary Outcomes
- 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)
- Couple Satisfaction Index-4 (CSI-4)(8-weeks postpartum)
- Postpartum Bonding Questionnaire (PBQ)(8-weeks postpartum)
- Five Minute Speech Sample (FMSS)(8-weeks postpartum)
- Qualitative Interview(8-weeks postpartum)
Investigators
Michelle Roley-Roberts
Assistant Professor
West Virginia University