Virtual patient navigation for postpartum depression during a pandemic

The Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Virtual Patient Navigation During a Pandemic

This study is testing a virtual support program to help women with postpartum depression who aren't currently getting mental health care during the pandemic.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Children's Hospital of Philadelphia (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06208852 on ClinicalTrials.gov

What this trial studies

This study aims to adapt an existing patient navigation intervention for virtual use to assist women experiencing postpartum depression. It involves two phases: a qualitative phase with semi-structured interviews to identify barriers to accessing mental health services, followed by an intervention phase where women with persistent symptoms will receive virtual navigation support over two months. The insights gained from the interviews will inform the adaptation of the intervention to better meet the needs of participants. The study targets women who are not currently engaged with mental health services and screens positive for postpartum depression.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old, with an infant under 12 months, who are not currently engaged with mental health services and screen positive for postpartum depression.

Not a fit: Patients who report severe depressive symptoms or suicidality may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could improve access to mental health support for women suffering from postpartum depression.

How similar studies have performed: Other studies have shown success with virtual mental health interventions, indicating potential for this adapted approach.

Eligibility criteria

Inclusion Criteria

Qualitative Phase:

Women who:

1. Are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.
2. Are \> 18 years of age
3. Speak and read in English
4. Have access to a smart phone or computer tablet with internet access
5. Have an infant \< 12 months of age

Intervention Phase:

Women who:

1. Are not actively engaged with MH services
2. Screen positive for postpartum depression (score\>9) on the EPDS
3. Are \> 18 years of age
4. Speak and read in English
5. Have access to a cellular phone with texting capabilities

Exclusion Criteria

Qualitative Phase:

Women who:

1. Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
2. Report severe depressive symptoms (EPDS\>20) at enrollment.
3. Have a substantiated report of child maltreatment

Children who:

1. Were born premature (estimated gestational age\<35 weeks)
2. Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
3. Are already currently receiving early intervention services for developmental delays at baseline

Intervention Phase:

Women who:

1. Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) with a response of "sometimes," or "yes, quite often" at participating pediatric practice
2. Report suicidality (i,e, suicidal ideation and/or behavior) on the EPDS (Question #10) and also endorse any of the follow up questions at a participating pediatric practice:

   i. Have you ever felt that life is not worth living? ii. Has this feeling occurred in the past week? iii. Have you ever wanted to kill yourself? iv. Did you ever make a plan to kill yourself? v. Have you ever attempted suicide?
3. Have a substantiated report of child maltreatment

Where this trial is running

Philadelphia, Pennsylvania

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: James Guevara, MD, MPH — Children's Hospital of Philadelphia
• Study coordinator: James Guevara, MD, MPH

Conditions Post-partum Depression; post-partum depression; mental health; child and maternal health; patient navigator