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).
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
146
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.
Brody School of Medicine Regional Perinatal Center
Greenville, North Carolina, United States
Pitt County Health Department
Greenville, North Carolina, United States
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.
Time frame: Post-treatment and 1-month follow-up and an equivalent time frame for the TAU group
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.
Time frame: Post-treatment and 1-month follow-up and an equivalent time frame for the TAU Group
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