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

Primary Purpose

Maternal Anxiety, Maternal Depression, Infant Cognitive Development

Status
Unknown status
Phase
Not Applicable
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Heartland Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Anxiety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Women who express suicidality

Sites / Locations

  • Heartland Alliance International

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions

Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection.

Outcomes

Primary Outcome Measures

Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist
Infant Cognitive Development as measured by Mullen Scales of Early Learning

Secondary Outcome Measures

Full Information

First Posted
September 19, 2016
Last Updated
September 20, 2016
Sponsor
Heartland Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT02911441
Brief Title
Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heartland Alliance

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Anxiety, Maternal Depression, Infant Cognitive Development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist
Time Frame
10 months post-birth of their infant
Title
Infant Cognitive Development as measured by Mullen Scales of Early Learning
Time Frame
10 months post-birth

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women in their third trimester of pregnancy Who exhibited symptoms of anxiety and depression Exclusion Criteria: Women who express suicidality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantin Kahorha
Organizational Affiliation
Heartland Alliance International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heartland Alliance International
City
Bukavu
State/Province
South Kivu
Country
Congo, The Democratic Republic of the

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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