NCT02911441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 19, 2016

Last Update Submit

September 20, 2016

Conditions

Maternal AnxietyMaternal DepressionInfant Cognitive Development

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy

Control Group

NO INTERVENTION

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

Interventions

Cognitive Behavioral TherapyBEHAVIORAL
Treatment Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Women who express suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heartland Alliance International

Bukavu, South Kivu, Democratic Republic of the Congo

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Constantin Kahorha

    Heartland Alliance International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 22, 2016

Study Start

December 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)