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

Postpartum depression (PPD) PPD affects 8-10% of men, and paternal anxiety affects up to 15% of men. Paternal mental health symptoms are often underdiagnosed and undertreated. It is hard to identify fathers who have mental health symptoms due to cultural conceptions of masculinity, leading to the risk that fathers do not recognize their symptoms as mental health symptoms and engage in avoidant or numbing behavior instead of appropriate treatment. Even if they recognize their mental health symptoms, men are less likely than women to pursue help due to the stigma of mental health care, resulting in delays in diagnosis and treatment. Fathers' lack of awareness and aversion to treatment leads to untreated PPD, which drastically increases risk of PPD for mothers and impaired cognitive development for children. Given the barriers fathers face being diagnosed with PPD and the lack of tailored treatment, a targeted intervention for fathers that effectively treats mental health symptoms and prevents worsening of these symptoms is urgently needed to decrease the risk of profound intergenerational consequences for fathers, mothers, and infants.

Interpersonal therapy (IPT) is an evidence-based psychotherapy approach for depression that views relationship attachments, effective communication, and disruption in social support as intimately linked with psychological symptoms. In 2019, the USPSTF's maternal PPD statement indicated IPT prevents maternal PPD. IPT may be even more suitable for paternal PPD prevention: fathers have been shown to prefer psychology over pharmacotherapy for PPD. In fact, IPT-based counseling has mechanistic plausibility to prevent paternal PPD: by helping fathers improve communication within their relationships, change expectations about those relationships, and/or build or better utilize an extended social support network, IPT can help fathers develop the interpersonal support needed to deal with the crises precipitating depressive symptoms (birth or infant care). It is also important to note that IPT has been shown to be an effective treatment for both anxiety and depression.

Online interventions reduce the stigma associated with mental health care, are widely utilized by men, and reduce depressive symptoms. Online peripartum mental health care effectively prevents and treats maternal PPD. Though there are currently no ongoing studies examining the effect of online IPT for paternal PPD prevention or treatment, online IPT will be accessible to most fathers: In the US, 90% of adults own a smartphone and 80% have home broadband internet. Also, unlike current IPT-based maternal mental health interventions, which require trained providers for intervention fidelity, online IPT could be disseminated without impacting intervention fidelity.

Together in Parenting (TIP) is a novel online paternal postpartum intervention that utilizes interpersonal-therapy-based strategies to reduce interparental conflicts and increase social support in the newborn period, thereby improve mental health symptoms among fathers. An iterative end-user centered design process allowed qualitative interviews with 25 fathers at high-risk of paternal PPD-as defined by the fact that their partners attended prenatal care at the clinic for federally insured pregnant people-to transform TIP's appearance and features. Specifically, TIP was originally conceptualized as a smartphone application but has evolved iteratively from feedback from target end-users during the qualitative interviews to become a scripted audio- and video-recorded podcast, mimicking friends casually discussing parenting and relationships. Each of the 12 podcasts, referred to as lessons on the website, range between 8 to 15 minutes (most are less than 11 minutes) and include a digital handout to encourage participant engagement with the progressive IPT-based curriculum. There are also 10 digital handouts to encourage engagement. TIP is hosted on a password-protected website. User-specific log-ins allow TIP to contain an embedded analytic platform to monitor duration of use and modules accessed as well as responses to digital handouts.

Thus, a pilot feasibility study is being conducted that examines the feasibility, acceptability, and preliminary estimates of effects of TIP as a paternal mental health program when compared to routine care (NCT07594743). During screening for eligibility, 20% of those screened cannot participate in this trial because they either endorse having depression or anxiety or screen positive for symptoms of depression or anxiety on baseline psychometric surveys. Given IPT can be used to treat these mental health symptoms, a second small feasibility and acceptability study is now being proposed to examine whether TIP can improve mental health symptoms among fathers with depression or anxiety.

For this pilot study, the primary purpose will not be to determine TIP's efficacy at improving paternal mental health symptoms but to demonstrate the feasibility and acceptability of TIP as a digital intervention among fathers with newly born infants and who have mental health symptoms. The dual primary outcome for this study will be feasibility and acceptability. In order to obtain a preliminary estimate of effect for TIP on PPD outcomes to support a future efficacy trial, the proposed pilot study will also assess clinically meaningful perinatal mental health outcomes (depression and anxiety) and mediators (dyadic adjustment, stress, loneliness, and parenting confidence). These metrics will be collected at multiple time points after randomization to allow for longitudinal assessment of symptom trajectories postpartum as well as pre/post-intervention analyses comparing scores at randomization to those at various postpartum intervals. The effect of TIP on maternal well-being will be examined by having mothers complete some psychometric at study completion. Lastly, the most effective timing of intervention delivery will be determined using a mixed-methods approach nested within the proposed pilot randomized trial.

• Feasibility: recruitment [Time frame: Prior to randomization]
• Acceptability: System Usability Scale [Time frame: 3 months postpartum]
• Paternal postpartum depressive symptoms [Time frame: Six or twelve weeks postpartum]
• Paternal postpartum anxiety symptoms [Time frame: Six or twelve weeks postpartum]
• Paternal postpartum perceived stress [Time frame: Six or twelve weeks postpartum]
• Paternal positive screens for mood disorders [Time frame: Six or twelve weeks postpartum]
• Maternal postpartum stress [Time frame: 12 weeks postpartum]