Together in Parenting for Postpartum Depression and Anxiety

(TIP-PLUS Trial)

SN
Overseen ByStephanie Nunes, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Women and Infants Hospital of Rhode Island
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for new or soon-to-be fathers who are experiencing symptoms of depression or anxiety after their child’s birth. Participants should be willing to use a digital program and engage with podcasts and educational materials.

Inclusion Criteria

Self-reported history of depression/anxiety or active depression/anxiety or screen positive on GAD-7 (8 or higher) or MDS (13 or higher)
English-speaking (for now, TIP is only available in English)
I am older than 18 years.
See 3 more

Exclusion Criteria

Endorsing active suicidality on intake survey
Prisoners
I am unable to give informed consent for my medical care.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Together in Parenting

Trial Overview

The study is testing 'Together in Parenting,' a digital program based on interpersonal therapy, which includes podcasts and handouts designed specifically to help new fathers manage postpartum depression or anxiety.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Together in Parenting (intervention)Experimental Treatment1 Intervention
Group II: Treatment As Usual (routine care)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials
119
Recruited
59,200+