A Public Health Program to Reduce Risk of Antepartum Depression
APD
A Behavioral Intervention to Reduce Risk of Antepartum Depression
2 other identifiers
interventional
146
1 country
2
Brief Summary
The hypotheses were as follows: H1. Women at low-moderate risk for APD at T1 (baseline EPDS scores of 5-9) in the cognitive behavioral intervention (CBI) group will maintain low-moderate risk status and have significantly fewer APD symptoms at T2 and T3 than women at low-moderate risk for APD in the (TAU) control group (as measured by percent of participants with EPDS scores \<9 at T2 and T3 and mean score changes). H2: Women at high risk for APD at T1 (baseline EPDS scores ≥10) in the CBI group will have a significantly greater reduction in APD symptoms at T2 and T3 than women at high risk for APD in the TAU control group (as measured by percent of participants with EPDS scores \<10 at T2 and T3 and mean score changes).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Dec 2010
Typical duration for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 20, 2014
CompletedFirst Posted
Study publicly available on registry
May 22, 2014
CompletedMay 22, 2014
May 1, 2014
2.9 years
May 20, 2014
May 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in Edinburgh Postpartum Depression Scale (EPDS) Scores from baseline to post intervention and 1-month follow-up
Outcomes were mean change in Edinburgh Postpartum Depression Scale (EPDS) Scores in the CBI and TAU women from baseline (T1) to post-treatment (T2) and 1-month follow-up (T3) in those at low-moderate and high-risk for antepartum depression.
Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group
Secondary Outcomes (1)
Mean change in antepartum Beck Depression Inventory (BDI-II) Scores from baseline to post intervention and 1-month follow-up
Post-treatment and 1-month follow-up and an equivalent time frame for the TAU Group
Other Outcomes (1)
Mean change scores of mediators and moderators related to the EPDS
Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group
Study Arms (2)
Insight-Plus Cognitive Behavioral Intervention
EXPERIMENTALInsight-Plus is a 6-session, manualized, cognitive behavioral intervention (CBI) culturally tailored for a diverse group of rural low-income women at low and high risk for antepartum depression.
Treatment as Usual (TAU)
NO INTERVENTIONTreatment as Usual (TAU) Control
Interventions
Insight-Plus is a 6-session, manualized, cognitive behavioral intervention (CBI) culturally tailored for a diverse group of rural low-income women at low and high risk for antepartum depression.
Eligibility Criteria
You may qualify if:
- years of age or older
- Between 6-30 weeks pregnant
- Enrolled as a patient at the local health department (LHD) or Brody School of Medicine Regional Perinatal Center (BSOM-RPC)
- Self-identified as African American, Caucasian, or Hispanic
- Able to read at a 4th grade level;
- Have a or score \>4 on the Edinburgh Postnatal Depression Scale (EPDS)
- Are willing to complete the informed consent form
- Enrolled in Medicaid or are low-income based on Women's Infant and Children (WIC) eligibility criteria.
You may not qualify if:
- Have had a spontaneous abortion before 20 weeks of pregnancy
- Diagnosed with schizophrenia or bipolar disorder with or without psychosis, or are currently receiving treatment for depression; or have an organic mental disorder
- Diagnosed with a high-risk pregnancy that requires bed rest or hospitalization-- Demonstrated an active suicidal plan
- Had a concurrent medical condition, such as hypothyroidism, that would explain depression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brody School of Medicine Regional Perinatal Center
Greenville, North Carolina, 27858, United States
Pitt County Health Department
Greenville, North Carolina, 27858, United States
Related Publications (1)
Jesse DE, Gaynes BN, Feldhousen EB, Newton ER, Bunch S, Hollon SD. Performance of a Culturally Tailored Cognitive-Behavioral Intervention Integrated in a Public Health Setting to Reduce Risk of Antepartum Depression: A Randomized Controlled Trial. J Midwifery Womens Health. 2015 Sep-Oct;60(5):578-92. doi: 10.1111/jmwh.12308. Epub 2015 Aug 10.
PMID: 26261095DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darlene E Jesse, PhD, CNM
East Carolina University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 20, 2014
First Posted
May 22, 2014
Study Start
December 1, 2010
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
May 22, 2014
Record last verified: 2014-05