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NCT02911441 Clinical Trial

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

Maternal Depression Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02911441
Other study ID # 0721-03
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 19, 2016
Last updated September 20, 2016
Start date December 2015
Est. completion date October 2016

Study information
Verified date September 2016
Source Heartland Alliance
Contact n/a
Is FDA regulated No
Health authority Canada: Grand Challenges Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 262
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women in their third trimester of pregnancy

- Who exhibited symptoms of anxiety and depression

Exclusion Criteria:

- Women who express suicidality

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive Behavioral Therapy

Locations
Country Name City State
Congo, The Democratic Republic of the Heartland Alliance International Bukavu South Kivu

Sponsors (1)
Lead Sponsor Collaborator
Heartland Alliance

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist 10 months post-birth of their infant No
Primary Infant Cognitive Development as measured by Mullen Scales of Early Learning 10 months post-birth No
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