NCT07594743 Feasibility and Acceptability of a Novel Digital Intervention to Prevent Paternal Postpartum Depression
| NCT ID | NCT07594743 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women and Infants Hospital of Rhode Island |
| Condition | Paternal Postpartum Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-07-07 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-07-07 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. The proposed pilot study will examine the feasibility and acceptability of using TIP as a paternal PPD intervention, will determine the optimal timing of administering TIP to future/new fathers, 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. Exclusion Criteria: 1. Any self-reported active diagnosis or history of mental health conditions including depression, anxiety, or other psychiatric condition, as per patient report; 2. Endorsing active suicidality on intake survey or screening positive on the MDS (≥13)16 or GAD-7 (≥8) at time of enrollment; 3. prisoners; 4. infant with genetic abnormality, significant anatomic malformation, or NICU admission at time of enrollment; 5. inability to consent. If new results on the MDS or GAD-7 indicate a positive screening or the father's infant(s) is diagnosed with a genetic abnormality, significant anatomic malformation, or NICU admission after the enrollment and randomization period, the father will still be eligible to continue participation in the study. This information will be tracked in the REDCap database.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07594743 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paternal Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07594743 currently recruiting?
Yes, NCT07594743 is actively recruiting participants. Contact the research team at snunez@wihri.org for enrollment information.
Where is the NCT07594743 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT07594743 clinical trial?
NCT07594743 is sponsored by Women and Infants Hospital of Rhode Island. The trial plans to enroll 90 participants.
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