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

• Sponsor: Heartland Alliance (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02911441
• Collaborator: (none)
• Enrollment: 262
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 26.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Anxiety; Maternal Depression; Infant Cognitive Development	Behavioral: Cognitive Behavioral Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions	Behavioral: Cognitive Behavioral Therapy
No Intervention: Control Group Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection.

Outcome Measures

Primary Outcome Measures

1. Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist [10 months post-birth of their infant]

2. Infant Cognitive Development as measured by Mullen Scales of Early Learning [10 months post-birth]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women in their third trimester of pregnancy

• Who exhibited symptoms of anxiety and depression

Exclusion Criteria:

• Women who express suicidality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heartland Alliance International	Bukavu	South Kivu	Congo, The Democratic Republic of the

Sponsors and Collaborators

• Heartland Alliance

Investigators

• Principal Investigator: Constantin Kahorha, Heartland Alliance International

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heartland Alliance
• ClinicalTrials.gov Identifier: NCT02911441
• Other Study ID Numbers: 0721-03
• First Posted: Sep 22, 2016
• Last Update Posted: Sep 22, 2016
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Sep 22, 2016