A Public Health Program to Reduce Risk of Antepartum Depression

Depression Clinical Trial

— APD  

Official title:

A Behavioral Intervention to Reduce Risk of Antepartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144844
• Other study ID #: 8045091
• Secondary ID: 1R34MH086680-01A
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: May 21, 2014
• Start date: December 2010
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Brody School of Medicine Regional Perinatal Center	Greenville	North Carolina
United States	Pitt County Health Department	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
East Carolina University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change scores of mediators and moderators related to the EPDS	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	No
Primary	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	Yes
Secondary	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.	Post-treatment and 1-month follow-up and an equivalent time frame for the TAU Group	Yes