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

NCT ID: NCT02911441

Last Updated: 2016-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Maternal Anxiety Maternal Depression Infant Cognitive Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Women who express suicidality
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Heartland Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Constantin Kahorha

Role: PRINCIPAL_INVESTIGATOR

Heartland Alliance International

Locations

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Heartland Alliance International

Bukavu, South Kivu, Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

Other Identifiers

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0721-03

Identifier Type: -

Identifier Source: org_study_id

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