Parenting intervention for postpartum depression in primary care
A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)
PHASE2 · University of Washington · NCT04998721
This study tests if a parenting program combined with regular care can help pregnant women in their second trimester who are dealing with postpartum depression feel better compared to just regular care alone.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04998721 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a parenting intervention combined with usual care compared to usual care alone for addressing postpartum depression and related mental health outcomes. Participants, who are pregnant women in their second trimester, will be randomly assigned to either the intervention group or the control group. The study will assess various outcomes during pregnancy and after childbirth to determine the feasibility and acceptability of the intervention.
Who should consider this trial
Good fit: Ideal candidates are English-speaking pregnant women aged 18 and older, between 13 to 24 weeks of gestation, with a score of 10 or higher on the Edinburgh Postnatal Depression Scale (EPDS).
Not a fit: Patients with severe substance use disorders, active suicidal ideation, bipolar disorder, psychotic disorders, multiple gestations, or those currently receiving psychotropic medications from a mental health specialist may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and parenting outcomes for new mothers experiencing postpartum depression.
How similar studies have performed: Other studies have shown promise in using similar dyadic approaches to address postpartum depression, indicating potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English speaking pregnant women between gestational age (GA) 13 - 24 weeks * ≥ 18 years, * EPDS score ≥10, * Ability to send and receive text messages (TM) Exclusion Criteria: * Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST). * Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS. * Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review); * Multiple gestation (assessed by self-report and medical record); * Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
Where this trial is running
Seattle, Washington
- Amritha Bhat — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Amritha S Bhat, MD, MPH — University of Washington
- Study coordinator: Amritha Bhat, MD
- Email: amritha@uw.edu
- Phone: 2065433117
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, Postpartum, Efficacy, Self, Anxiety