Clinical trial NCT04998721: A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care
Official title: A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care (MInD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Depression, Postpartum
Efficacy, Self
Anxiety
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-08-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Secondary outcomes:
measure: Change from Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR)
timeFrame: Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
measure: Change from Postpartum Baseline in Dyadic Interaction
timeFrame: 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
measure: Change from Baseline in Disability on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
measure: Change from Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF)
timeFrame: 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
measure: Relative utilization of MInD vs usual CC
timeFrame: Baseline through up to 6 Months Postpartum (up to maximum of 9 months)
measure: Perceived match of treatment to patient need using Working Alliance Inventory (WAI-SR)
timeFrame: 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Amritha Bhat
state: Washington
Study officials:
affiliation: University of Washington
name: Amritha S Bhat, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: