A Public Health Program to Reduce Risk of Antepartum Depression (APD)

May 21, 2014 updated by: Darlene Elizabeth Jesse, East Carolina University

A Behavioral Intervention to Reduce Risk of Antepartum Depression

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We collected data using Netbooks computers pre-programmed with Qualtrics survey forms.

At baseline (T1), post intervention (T2) and 1-month follow-up (T3), participants were administered the EPDS and the BDI-II and the Dolphin MINI neuropsychiatric Interview version 6. A similar time frame was used for the TAU group. Paired T-tests were used to determine mean change in EPDS scores (primary analysis) and BDI-II scores (secondary analysis) within each of the CBI and TAU groups at T2 and T3. A T-test measured differences in EPDS and BDI-II scores for the same time periods.

  • The sample size was based on the PI's pilot intervention study. Using a conservative estimate of 500 eligible women from both sites per year at a 42% depression risk rate (moderate and high), and a 46% enrollment rate, it will be possible to accrue 97 subjects per year at risk for APD (moderate and high risk) or 193 subjects over the first 24 months of the study. Using the recruitment, retention, and eligibility patterns from the previous study, a total study sample of 124 subjects, 62 in the IP-CBI group and 62 in the TAU control group, allows for a 20% (24) drop-out rate and achieve the goal of 50 women in the IP-CBI and 50 women in the TAU control group.
  • We planned to determine if there were significant differences in EPDS baseline scores in the CBI and TAU groups for the full sample and for the CBI and TAU groups stratified by high or low-moderate risk for antepartum depression.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • Brody School of Medicine Regional Perinatal Center
      • Greenville, North Carolina, United States, 27858
        • Pitt County Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Insight-Plus Cognitive Behavioral Intervention
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.
Behavioral: Insight-Plus Cognitive Behavioral Intervention
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.
NO_INTERVENTION: Treatment as Usual (TAU)
Treatment as Usual (TAU) Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in Edinburgh Postpartum Depression Scale (EPDS) Scores from baseline to post intervention and 1-month follow-up
Time Frame: Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in antepartum Beck Depression Inventory (BDI-II) Scores from baseline to post intervention and 1-month follow-up
Time Frame: Post-treatment and 1-month follow-up and an equivalent time frame for the TAU Group
Outcomes were mean change in Beck Depression Inventory (BDI-II) 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change scores of mediators and moderators related to the EPDS
Time Frame: Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group
Mean change scores of mediators and moderators related to the EPDS mean T1-T2 and T1-T3 change scores within the CBI and the TAU control group
Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Darlene E Jesse, PhD, CNM, East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (ESTIMATE)

May 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8045091
  • 1R34MH086680-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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