A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)

University of Washington

Status and phase: Enrolling; Phase 2

Conditions: Depression, Postpartum; Anxiety; Efficacy, Self

Treatments: Behavioral: Promoting First Relationships-Brief; Behavioral: Perinatal Collaborative Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04998721

STUDY00011405

1R34MH124798-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Eligible and consenting participants will be randomized in a single blind manner (research visitor will be blinded to condition) at a 1:1 ratio to either MInD (parenting intervention and usual perinatal collaborative care) or usual collaborative care in their second trimester of pregnancy. Research assessments will be administered during pregnancy and post-partum.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Maternal Infant Dyadic Care

Experimental group

Description:

Perinatal collaborative care and Promoting First Relationships-Brief

Treatment:

Behavioral: Promoting First Relationships-Brief

Behavioral: Perinatal Collaborative Care

Control

Active Comparator group

Description:

Perinatal collaborative care only

Treatment:

Behavioral: Perinatal Collaborative Care