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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insight-Plus Cognitive Behavioral Intervention
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Antepartum depressive symptoms, Antepartum depression, Cognitive behavioral intervention, Feasibility, randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Brody School of Medicine Regional Perinatal Center
  • Pitt County Health Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Insight-Plus Cognitive Behavioral Intervention

Treatment as Usual (TAU)

Arm Description

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.

Treatment as Usual (TAU) Control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean change in antepartum Beck Depression Inventory (BDI-II) Scores from baseline to post intervention and 1-month follow-up
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.

Full Information

First Posted
May 20, 2014
Last Updated
May 21, 2014
Sponsor
East Carolina University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02144844
Brief Title
A Public Health Program to Reduce Risk of Antepartum Depression
Acronym
APD
Official Title
A Behavioral Intervention to Reduce Risk of Antepartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Antepartum depressive symptoms, Antepartum depression, Cognitive behavioral intervention, Feasibility, randomized clinical trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insight-Plus Cognitive Behavioral Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
Treatment as Usual (TAU) Control
Intervention Type
Behavioral
Intervention Name(s)
Insight-Plus Cognitive Behavioral Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in Edinburgh Postpartum Depression Scale (EPDS) Scores from baseline to post intervention and 1-month follow-up
Description
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.
Time Frame
Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group
Secondary Outcome Measure Information:
Title
Mean change in antepartum Beck Depression Inventory (BDI-II) Scores from baseline to post intervention and 1-month follow-up
Description
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.
Time Frame
Post-treatment and 1-month follow-up and an equivalent time frame for the TAU Group
Other Pre-specified Outcome Measures:
Title
Mean change scores of mediators and moderators related to the EPDS
Description
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
Time Frame
Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darlene E Jesse, PhD, CNM
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brody School of Medicine Regional Perinatal Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Pitt County Health Department
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26261095
Citation
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.
Results Reference
derived

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A Public Health Program to Reduce Risk of Antepartum Depression

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