AI Chatbot for Postpartum Loneliness

(PEARL Trial)

Overseen By Cecile Ferrando, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Multiparous, Major neonatal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new AI chatbot to determine if it can help new mothers feel less lonely and improve their understanding of pelvic floor health after childbirth. Participants will receive either standard postpartum care or standard care plus access to the chatbot (Postpartum Education Via Artificial Intelligence) for additional support and information over four weeks. The study will compare both groups to assess whether the chatbot improves knowledge about pelvic health, reduces loneliness, and affects pelvic symptoms. New mothers who gave birth 2-6 weeks ago, delivered vaginally or by C-section, speak English, and have access to a smartphone and the internet are eligible to join. As an unphased trial, this study provides a unique opportunity for new mothers to access innovative support and contribute to valuable research.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a chatbot for support, so it's unlikely that medication changes are required.

What prior data suggests that this AI chatbot is safe for postpartum mothers?

Research has shown that using AI chatbots in healthcare is generally safe. In past studies, chatbots supported mental health without major safety issues. These digital tools provide information and emotional support without involving medications or physical treatments that might cause side effects.

Experts designed the chatbot in this trial to help new mothers with information and support after childbirth. It aims to increase understanding of pelvic floor health and reduce feelings of loneliness. As a digital tool offering advice and support, it poses little risk to physical health. However, following the instructions and using the chatbot as recommended is important for the best experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Generative AI Chatbot Intervention for postpartum loneliness because it introduces an innovative way to deliver postpartum education and support. Unlike traditional support methods, such as in-person therapy or support groups, this AI-driven chatbot offers personalized, real-time interaction that is easily accessible for new mothers. It provides a novel mechanism by using artificial intelligence to engage users in meaningful conversations, potentially reducing feelings of isolation more effectively and conveniently than standard care. This approach could revolutionize how postpartum support is provided, making it more adaptable to individual needs and schedules.

What evidence suggests that this AI chatbot is effective for postpartum loneliness?

Research has shown that AI chatbots can assist new mothers after childbirth. In this trial, participants may receive the Generative AI Chatbot Intervention, designed to provide personalized, evidence-based advice instantly. One study found that these tools can educate mothers about pelvic floor health, which is crucial after childbirth. Another study demonstrated that AI chatbots can offer emotional support, potentially reducing feelings of loneliness and helping new mothers manage their mental health more effectively. Overall, early evidence suggests that AI chatbots could enhance postpartum care by providing both educational support and emotional comfort. Meanwhile, other participants will receive standard postpartum care, serving as a comparison to evaluate the effectiveness of the AI chatbot intervention. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for new mothers over 18 years old who have recently given birth (2-6 weeks ago), either vaginally or via cesarean, and are experiencing their first childbirth. Participants must speak English, be able to consent, follow the study procedures, have internet access and a smartphone.

Inclusion Criteria

Primiparous

English Speaking

Internet access and proficiency of internet access

Exclusion Criteria

Multiparous

Major neonatal anomaly

Delivery < 34 weeks gestational age

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the chatbot group receive education and support via the chatbot over a 4-week period

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Postpartum Education Via Artificial Intelligence

Trial Overview The trial is testing if a chatbot using generative AI can improve postpartum pelvic floor health knowledge and reduce loneliness compared to standard care alone. New moms will be randomly assigned to receive either standard care or standard care plus chatbot support for four weeks.

How Is the Trial Designed?

Group I: Generative AI Chatbot Intervention Experimental Treatment 2 Interventions

Generative AI Chatbot Intervention

Group II: Standard postpartum care Active Control 1 Intervention

Standard postpartum care

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07223736

Study Details | NCT07223736 | Postpartum Education Via ... Rutledge et al., performed a randomized controlled trial assessing peripartum pelvic floor health knowledge as measured with the Prolapse and Incontinence ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12124027/

Artificial intelligence-assisted chatbot: impact on ... This study investigates the impact of a mobile breastfeeding counseling application developed with artificial AI on mothers' breastfeeding self-efficacy, ...

4. texascommunityhealthnews.org texascommunityhealthnews.org/reports/2023/postpartum.html

AI chatbots could fill gaps in postpartum depression ... She often observes new mothers attempting to ignore their emotions. Many women “shrug off” symptoms of Perinatal Mood and Anxiety Disorder (PMAD) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0010482524007704

Artificial intelligence in perinatal mental health research A study reported that around 10%–25 % of mothers experienced postpartum depression (PPD) [6]. In the UK, the National Health Service (NHS) reported that more ...

6. nature.com nature.com/articles/s44401-025-00030-7

applying artificial intelligence to the perinatal mental health ... The perinatal mental health care cascade is wrought with systemic issues contributing to under-detection and outcome disparities.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12440769/

Artificial intelligence-oriented predictive model for the risk of ... Postpartum depression (PPD) is a significant mental health concern affecting 3.5-33.0% of mothers worldwide, with potentially severe ...