A Phase 2 interventional study of Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs) in Depression, sponsored by Johns Hopkins University. Completed at 4 sites in United States. Open to female participants aged 14 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-07.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Prevention
The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.
This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child \< 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 82 is close to the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Johns Hopkins University is the lead sponsor of 1,782 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women in the intervention condition will receive 6 two-hour intervention sessions delivered weekly in a group format by the Study Clinician. Each session contains didactic instruction on core content, as well as activities and group discussion. One of the strengths of embedding the MB Course within home visiting is our ability to have home visitors reinforce the material presented by the Study Clinician. The 6-week curriculum is divided into three modules: (a) pleasant activities, (b) thoughts, and (c) relationships with others. Each module has two sessions. These sessions map onto core cognitive-behavioral concepts.
Behavioral: Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
Women in the control group will receive usual home visiting services and information on postpartum depression.
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format
Depressive symptoms
Time frame: Baseline
Depressive symptoms
Time frame: 1 week post intervention
Depressive Symptoms
Time frame: 3 months post-intervention
Depressive symptoms
Time frame: 6 months post-intervention
Depressive episodes
Time frame: 3 months post-intervention
Depressive Episodes
Time frame: 6 Months Post-Intervention
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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