IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression
NCT ID: NCT06746337
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2025-03-10
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
IMAGINE
IMAGINE is a digital group cognitive behavioral therapy intervention
Control
Control participants will be provided with standardized information about signs and symptoms of perinatal depression and will continue to receive standard healthcare.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IMAGINE
IMAGINE is a digital group cognitive behavioral therapy intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
16 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
Northwestern University
OTHER
Brown University
OTHER
Seattle Children's Hospital
OTHER
National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Keshet Ronen
Assistant Professor, Global Health
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Keshet Ronen, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Perinatal Support Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Desiree Israel
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00019195
Identifier Type: -
Identifier Source: org_study_id