Clinical trial NCT06746337: IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression
Official title: IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression During Pregnancy
Depression, Postpartum
Keywords: digital
perinatal
depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Northwestern University
name: Brown University
name: Seattle Children's Hospital
name: National Institute of Mental Health (NIMH)
First posted: 2024-12-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Depression symptoms
timeFrame: 24 weeks
Secondary outcomes:
measure: Depression symptoms
timeFrame: 24 weeks
measure: Anxiety symptoms
timeFrame: 24 weeks
Other outcomes:
measure: Negative mood deregulation
timeFrame: 24 weeks
measure: Perceived social support
timeFrame: 24 weeks
measure: Perceived stress
timeFrame: 24 weeks
measure: Behavioral activation
timeFrame: 24 weeks
measure: Decentering
timeFrame: 24 weeks
Locations:
city: Seattle
country: United States
facility: Perinatal Support Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Keshet Ronen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: