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

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ClinicalTrials.gov Identifier: NCT02144844
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Darlene Elizabeth Jesse, East Carolina University

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).


Condition or disease Intervention/treatment Phase
Depression Behavioral: Insight-Plus Cognitive Behavioral Intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Behavioral Intervention to Reduce Risk of Antepartum Depression
Study Start Date : December 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144844


Locations
United States, North Carolina
Brody School of Medicine Regional Perinatal Center
Greenville, North Carolina, United States, 27858
Pitt County Health Department
Greenville, North Carolina, United States, 27858
Sponsors and Collaborators
East Carolina University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Darlene E Jesse, PhD, CNM East Carolina University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Darlene Elizabeth Jesse, Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT02144844     History of Changes
Other Study ID Numbers: 8045091
1R34MH086680-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by Darlene Elizabeth Jesse, East Carolina University:
Antepartum depressive symptoms
Antepartum depression
Cognitive behavioral intervention
Feasibility
randomized clinical trial

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders