Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments

Not Applicable

• Conditions: Maternal Depression; Infant Cognitive Development; Maternal Anxiety
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT02911441
• Lead Sponsor: Heartland Alliance

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-09
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-20
• Last Update Submitted: 2016-09-20
• Study First Posted: 2016-09-22
• Last Update Posted: 2016-09-22
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 262

Inclusion Criteria

• Women in their third trimester of pregnancy
• Who exhibited symptoms of anxiety and depression

Exclusion Criteria

• Women who express suicidality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Cognitive Behavioral Therapy	Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions

Primary Outcome Measures

Name	Time	Method
Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist	10 months post-birth of their infant
Infant Cognitive Development as measured by Mullen Scales of Early Learning	10 months post-birth

Trial Locations

Locations (1)

Heartland Alliance International; 🇨🇩 Bukavu, South Kivu, Congo, The Democratic Republic of the