Overview

This trial is active, not recruiting.

Conditions maternal anxiety, maternal depression, infant cognitive development
Treatment cognitive behavioral therapy
Sponsor Heartland Alliance
Start date December 2015
End date October 2016
Trial size 262 participants
Trial identifier NCT02911441, 0721-03

Summary

This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.

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 treatment
Arm
(Experimental)
Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions
cognitive behavioral therapy
(No Intervention)
Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection.

Primary Outcomes

Measure
Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist
time frame: 10 months post-birth of their infant
Infant Cognitive Development as measured by Mullen Scales of Early Learning
time frame: 10 months post-birth

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Women in their third trimester of pregnancy - Who exhibited symptoms of anxiety and depression Exclusion Criteria: - Women who express suicidality

Additional Information

Principal investigator Constantin Kahorha
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Heartland Alliance.