NCT03378544

Brief Summary

Evidence from Low and Middle Income Countries has demonstrated the effectiveness of various psychosocial approaches for depression. However, there are no mental health specialists to deliver these interventions especially in rural African settings. This study aims at testing the effectiveness of mental health Global Action Programme (mhGAP-IG) psychosocial interventions among Traditional Birth Attendants (TBAs) for pregnant mothers. The outcomes of this intervention will result into depression reduction in the mothers that will lead to better care during pregnancy and for their infants, allowing for long-term impact on their physical and the psychological wellbeing and that of their children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 5, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

December 5, 2017

Last Update Submit

September 30, 2025

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Reduction in depressive symptoms

    The proportion of patients (mothers with maternal depression) with reduction of depressive symptoms at 3, 6, and 9 months from baseline, using the Edinburgh Postnatal Depression Scale. This tool has adequate sensitivity and specificity to identify depressive symptoms in the antenatal and postnatal periods. A score is calculated by adding the individual items for each question. A total score of 11 or more in the Kenyan context is considered a flag for the need for follow up of possible depressive symptoms.

    0, 3, 6, and 9 months

Secondary Outcomes (5)

  • Intimate Partner violence

    Baseline

  • Quality of life of mothers with depression

    0, 3, 6, and 9 months

  • Satisfaction levels

    0, 3, 6, and 9 months

  • Suicidality

    0, 3, 6, and 9 months

  • Disability

    0, 6, and 9 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients with suicidal ideation and depression will receive psychosocial interventions adapted from the WHO mental health Global Action Programme Intervention Guide (mhGAP-IG). The intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity.

Behavioral: mhGAP

Control group

NO INTERVENTION

Patients with suicidal ideation and depression will be trained on how to refer patients suffering from depression, using a referral note to the nearest health centre for further treatment

Interventions

mhGAPBEHAVIORAL

The intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity

Experimental arm

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant mothers seeking the services of traditional birth attendants
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Gestational age of between 16 and 26 weeks
  • A positive score on EPDS
  • Confirmed diagnosis of depression using the Mini International Psychiatric Interview
  • Provision of an informed consent

You may not qualify if:

  • Actively suicidal
  • Severe mental disorders and/or medical conditions requiring immediate medical attention
  • A negative score on EPDS
  • Pregnancy-related complications
  • Decline to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tawa and Kanzokea

Makueni Boma, Makueni County, Kenya

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Christine W Musyimi

    Africa Institute of Mental and Brain Health (AFRIMEB)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 20, 2017

Study Start

April 9, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)