Recruiting
Phase 2

Perinatal Depression

Sponsor:

University of Washington

Code:

NCT04998721

Conditions

Depression, Postpartum

Efficacy, Self

Anxiety

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Promoting First Relationships-Brief

Perinatal Collaborative Care

Study Details

Brief summary:

The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.

Conditions

Depression, Postpartum

Efficacy, Self

Anxiety

Study ID

NCT04998721

Start date

Nov 1, 2022

Status verified date

Nov, 2023

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Mar 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maternal Infant Dyadic Care

Perinatal collaborative care and Promoting First Relationships-Brief

active comparator: Control

Perinatal collaborative care only

Interventions

Promoting First Relationships-Brief

A brief version of the evidence based Promoting First Relationships (PFR) parenting intervention in which a parent is supported in appropriate interpretation of infant cues and in developing skills to effectively parent an infant. Sessions consist of reflective content (observing and reflecting back to the mother on patterns of dyadic interaction) and informational handouts. Reflective content will be delivered in person, and text messaging protocol will deliver informational content at developmentally appropriate times. PFR-B sessions are delivered in primary care settings beginning in the third trimester and continuing postpartum.

Perinatal Collaborative Care

Collaborative Care (CC) is an integrated care model that is effective in the treatment of perinatal depression. CC provides team driven, population focused, measurement guided and evidence based care to improve access and outcomes, control costs, and increase patient satisfaction.

Primary outcome measure

  • Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum ]

Central Contacts and Locations

Central contacts

Amritha Bhat, MD

2065433117amritha@uw.edu

Jamie Adachi, MPH

jadachi@uw.edu

Locations

Amritha Bhat

Recruiting

Seattle, Washington, United States, 98195

Contacts

Amritha Bhat

206-543-3117amritha@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Dec 22, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2023-12-22.