Digital group intervention to prevent perinatal depression
IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression
NA · University of Washington · NCT06746337
This study tests a new online group program to see if it can help pregnant women and new moms at risk for depression feel better compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06746337 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the IMAGINE digital group intervention aimed at preventing depression in perinatal populations. Participants will be randomized to either the IMAGINE group for 12 weeks or receive standard care, with assessments of depression scores and intervention feasibility. The study will refine the intervention through qualitative feedback and measure its effectiveness in engaging cognitive behavioral therapy targets. The trial will include participants who are pregnant or up to 6 months postpartum and at elevated risk for perinatal depression.
Who should consider this trial
Good fit: Ideal candidates are individuals who are pregnant or up to 6 months postpartum, aged 16 or older, and at elevated risk for perinatal depression.
Not a fit: Patients currently experiencing major depression or those not at elevated risk for perinatal depression may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of perinatal depression among at-risk populations.
How similar studies have performed: Other studies have shown promise in using digital interventions for mental health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- Perinatal Support Washington — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Keshet Ronen, PhD, MPH — University of Washington
- Study coordinator: Keshet Ronen, PhD, MPH
- Email: keshet@uw.edu
- Phone: 206-685-4363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression During Pregnancy, Depression, Postpartum, digital, perinatal, depression