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

NCT06746337 | Active Not Recruiting

• 2 other identifiers: STUDY00019195R34MH131571
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression During Pregnancy; Depression, Postpartum

Keywords

digital; perinatal; depression

Outcome Measures

Primary Outcomes (1)

• Depression symptoms

  Ascertained by Beck Depression Inventory (score 0-63, higher score means worse outcome)

  24 weeks

Secondary Outcomes (2)

• Depression symptoms

  24 weeks

• Anxiety symptoms

  24 weeks

Other Outcomes (5)

• Negative mood deregulation

  24 weeks

• Perceived social support

  24 weeks

• Perceived stress

  24 weeks

Study Arms (2)

IMAGINE

EXPERIMENTAL

The intervention is a digital adaptation of the evidence-based Mothers and Babies program, delivered interactively to groups of perinatal people and facilitated by a mental health provider.

Behavioral: IMAGINE

Control

NO INTERVENTION

Control participants will be provided with standardized information about signs and symptoms of perinatal depression and will continue to receive standard healthcare.

Interventions

IMAGINE BEHAVIORAL

IMAGINE is a digital group cognitive behavioral therapy intervention

IMAGINE

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of Washington: lead
• Brown University: collaborator
• Seattle Children's Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Northwestern University: collaborator

Study Sites (1)

Perinatal Support Washington

Seattle, Washington, 98103, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Keshet Ronen, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 24, 2024
• Study Start: March 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 1/31/2027 - indefinite
• Access Criteria: Data is publicly available after creating an account with the NIMH NDA

Locations

US (1)