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

NCT06746337 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Depression During Pregnancy
  • Depression, Postpartum

Interventions

BEHAVIORAL

IMAGINE

IMAGINE is a digital group cognitive behavioral therapy intervention

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Northwestern University

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Keshet Ronen, PhD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746337 on ClinicalTrials.gov