In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Denver

About this trial

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English or Spanish speaking

Less than 30 gestational weeks

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • ROSE Program: In Person

    Behavioral

    In-person preventative intervention for postpartum depression that includes content on building social support and communication skills in relationships, navigating the role transition to motherhood, and learning about signs and symptoms of depression after delivery.

  • ROSE Program: Virtual

    Behavioral

    Virtual ROSE covers the same content (e.g. improving social support and communication) and is delivered by the same facilitators as the in-person intervention via telehealth.

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: In-Person Delivery of Group Preventative Intervention (ROSE)Active comparator 1 intervention
Group B: Virtual Delivery of Group Preventative Intervention (ROSE)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Symptom Checklist 20 (SCL 20)

Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

Time frame
6 weeks after birth
2

Symptom Checklist 20 (SCL 20)

Self reported depression scores.Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

Time frame
3 months after birth
3

Symptom Checklist 20 (SCL 20)

Self reported depression scores

Time frame
6 months after birth
4

Symptom Checklist 20 (SCL 20)

Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.

Time frame
12 months after birth

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Denver

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Denver Health Medical Center

Collaborator