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Recruiting NCT06746337

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

Trial Parameters

Condition Depression During Pregnancy
Sponsor University of Washington
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex FEMALE
Min Age 16 Years
Max Age N/A
Start Date 2025-03-10
Completion 2026-10-31
Interventions
IMAGINE

Brief 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 Criteria

Inclusion Criteria: * Pregnant or up to 6 months postpartum * Age 16 or over * At elevated risk of perinatal depression (per USPSTF) * Speaks English or Spanish * PHQ9\<15 and no current major depression * Access to a smartphone with cellular data at least 3 days per week * If receiving other mental healthcare services, has been established in care at least 6 months and on stable treatment regimen Exclusion Criteria: none

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