Clinical Trial

Feasibility and Acceptability of a Novel Digital Intervention For Perinatal Men Who Have Depression or Anxiety

Study acronym: TIP-PLUS
Not Yet Recruiting
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Summary
Postpartum depression (PPD) occurs almost as often among men as it does among women. However, while there have been multiple programs designed to prevent maternal PPD, few, if any, interventions exist that have been created specifically to prevent paternal PPD. After engaging in evidence-based qualitative research with soon-to-be or new fathers, a novel interpersonal-therapy based digital program was created to prevent paternal PPD called Together in Parenting (TIP), which comprises multiple podcasts and digital educational handouts. While screening for eligibility for an ongoing pilot feasibility trial (NCT07594743), 20% of those were ineligible because they either endorsed having depression or anxiety or screened positive on psychometric surveys for having moderate symptoms of these conditions. TThe proposed pilot study will examine the feasibility and acceptability of using TIP as an intervention for fathers who have mental health symptoms, and will generate preliminary estimates of effect of the intervention to support a future efficacy study.
Trial Details
NCT Number NCT07742566
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions Paternal Postpartum Depression, Postpartum Anxiety
Enrollment 45 participants
Start Date 2026-09-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07