Overview

This trial is active, not recruiting.

Condition depression
Treatment mothers and babies course (adapted for baltimore home visiting programs)
Phase phase 2
Sponsor Johns Hopkins University
Collaborator Abell Foundation
Start date October 2009
End date October 2010
Trial size 91 participants
Trial identifier NCT01175603, ICTR 2009, JHMI ICTR 2009

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
mothers and babies course (adapted for baltimore home visiting programs)
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format
(No Intervention)
Women in the control group will receive usual home visiting services and information on postpartum depression.
mothers and babies course (adapted for baltimore home visiting programs)
6 weekly 2-hour cognitive-behavioral intervention sessions held in group format

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Depressive episodes
time frame: 3 months post-intervention
Depressive Episodes
time frame: 6 Months Post-Intervention

Eligibility Criteria

Female participants from 14 years up to 50 years old.

Inclusion Criteria: - pregnant or has child < 6 months of age - enrolled in home visiting program - exhibiting elevated depressive symptoms and/or personal history of clinical depression Exclusion Criteria: - no current clinical depression at time of enrollment

Additional Information

Principal investigator Shiv D Tandon, PhD
Description This study will conduct a 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 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Johns Hopkins University.