RecruitingNot ApplicableNCT06746337

IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression

Sponsor

University of Washington

Enrollment

100 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Depression During Pregnancy Depression, Postpartum

Summary

The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are: Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible? Participants will be randomized to either participate in an IMAGINE group for 12 weeks or receive standard of care. Participants will respond to questionnaires at enrollment and study visits at 12 and 24 weeks after enrollment.

Eligibility

Sex: FEMALEMin Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This pilot study tests a digital group program (delivered online) designed to prevent perinatal depression — depression that occurs during pregnancy or in the first year after giving birth — in people who are at elevated risk. The program is available in English and Spanish. **You may be eligible if...** - You are currently pregnant or up to 6 months postpartum - You are 16 years of age or older - You are at elevated risk for perinatal depression (as defined by USPSTF guidelines) - You have mild or no current depressive symptoms (PHQ-9 score below 15) - You speak English or Spanish - You have access to a smartphone with cellular data at least 3 days a week **You may NOT be eligible if...** - You currently have a major depressive episode (PHQ-9 ≥ 15) - You are receiving mental health care and have not been on a stable treatment for at least 6 months There are no exclusion criteria listed beyond the above. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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