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Not Yet Recruiting NCT07742566

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

Conditions: Paternal Postpartum Depression, Postpartum Anxiety

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Women and Infants Hospital of Rhode Island

Location: Women & Infants Hospital of Rhode Island Providence Rhode Island

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.

Eligibility Criteria

Inclusion Criteria: 1. English-speaking (for now, TIP is only available in English) 2. age \>18 years old, 3. smartphone ownership or access to home internet, 4. partner or patient received or receiving prenatal care from a resident or nurse-practitioner/midwifery clinic at the Obstetrics and Gynecologic Care Center (OGCC) at Women \& Infants Hospital of Rhode Island (WIHRI) or receiving an ultrasound at the WIHRI's Prenatal Diagnosis Center , 5. planned delivery or status post delivery at WIHRI. 6. self-reported history of depression/anxiety or active depression/anxiety or screen positive on GAD-7 (8 or higher) or MDS (13 or higher) Exclusion Criteria: 1. Endorsing active suicidality on intake survey; 2. prisoners; 3. infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment; 4. inability to consent.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07742566). StuddyBuddy aggregates publicly available trial information.