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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression, Postpartum; Depression During Pregnancy
• Intervention / Treatment: Behavioral: IMAGINE

Detailed Description

Perinatal depression affects an estimated 13% of pregnant people in the US. While effective interventions exist to prevent perinatal depression, access to facility-based in-person interventions is limited. This proposal will refine a digital group adaptation of an evidence-based prevention intervention, and evaluate its preliminary effectiveness and implementation outcomes through a pilot randomized controlled trial.

The proposal consists of 3 specific aims:

Aim 1. Using human-centered design, refine the IMAGINE intervention for implementation within perinatal mental health services in Washington State. Building off existing IMAGINE intervention materials, we will conduct qualitative interviews and focus groups with perinatal people, service providers, administrators, and payers to refine:

1. IMAGINE intervention design to meet the needs of perinatal clients age 16-35. Components to be optimized include message frequency, balance of synchronous and asynchronous content, and group composition.
2. IMAGINE implementation protocols and materials to support delivery by our implementation partner.

Hypothesis: Combined synchronous and asynchronous content and delivery compliant with billable health services will be preferred.

Aim 2. Determine IMAGINE's preliminary effectiveness engaging CBT targets and preventing depression.

A pilot RCT will be conducted comparing IMAGINE (as optimized in Aim 1) delivered in English or Spanish vs. treatment as usual, among 100 perinatal participants (pregnant or ≤6 months postpartum) with one or more risk factors for perinatal depression (as defined by USPSTF) and no current major depression. Participants will be recruited from our partner organization's clients. We will compare longitudinal change in depression symptoms and engagement of target mechanisms (negative mood regulation, perceived stress, and perceived social support) between arms at enrollment, 12- and 24-weeks post-enrollment. Exploratory analyses will assess effect modification by participant age, race/ethnicity, pregnancy status, and language.

Hypothesis: IMAGINE will lead to moderate reduction in depression symptoms, with effect size similar to MB.

Aim 3. Determine IMAGINE's preliminary implementation outcomes (acceptability, appropriateness, usability, and feasibility) among client, provider, administrator, and payer stakeholders.

Acceptability, appropriateness and usability among RCT participants will be assessed based on quantitative questionnaires, engagement in IMAGINE, and qualitative interviews. Provider, administrator, and payer acceptability, feasibility, and appropriateness will be determined through group discussion of IMAGINE RCT process indicators. We will explore client and contextual determinants of implementation outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98103
      • Perinatal Support Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMAGINE; 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; IMAGINE is a digital group cognitive behavioral therapy intervention
No Intervention: Control; Control participants will be provided with standardized information about signs and symptoms of perinatal depression and will continue to receive standard healthcare.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	Ascertained by Beck Depression Inventory (score 0-63, higher score means worse outcome)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	Ascertained by Patient Health Questionnaire 9 (score 0-27, higher score means worse outcome)	24 weeks
Anxiety symptoms	Ascertained by Generalized Anxiety Disorder 7 (score 0-21, higher score means worse outcome)	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative mood deregulation	Ascertained by Negative Mood Regulation Scale (score 30-150, higher score means better outcome)	24 weeks
Perceived social support	Ascertained by Medical Outcomes Survey (score 0-100, higher score means better outcome)	24 weeks
Perceived stress	Ascertained by Perceived Stress Scale 10 (score 0-40, higher score means worse outcome)	24 weeks
Behavioral activation	Ascertained by Behavioral Activation for Depression Scale (score 0-150, higher score means better outcome)	24 weeks
Decentering	Ascertained by Experiences Questionnaire (score 20-100, higher score means better outcome)	24 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); Northwestern University; Brown University; National Institutes of Health (NIH); Seattle Children's Hospital
• Investigators: Principal Investigator: Keshet Ronen, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: depression; perinatal; digital
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Depressive Disorder; Behavior; Depression; Depression, Postpartum
• Other Study ID Numbers: STUDY00019195; R34MH131571 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This project is required to deposit mental health outcomes data in the NIMH National Data Archive (NDA). NDA uses direct identifies to generate global unique identifiers, but the identifiers themselves will not be shared.
• IPD Sharing Time Frame: 1/31/2027 - indefinite
• IPD Sharing Access Criteria: Data is publicly available after creating an account with the NIMH NDA
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No