Clinical trial NCT03378544: Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya
Official title: Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Africa Mental Health Foundation
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: 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 seeking the services of TBAs and suffering from maternal depression.

A cluster randomized controlled trial with two sub-counties in Makueni County (rural Kenya) as the clusters, randomized into either intervention or control arms will be used. TBAs in the intervention arm will receive training on mhGAP-IG while those in the control arm will only be requested to refer patients to nearest clinics and continue with their routine care, except in circumstances of pregnancy-related complications or severe medical conditions. All pregnant mothers will be eligible for inclusion.

Qualitative measures will be used to explore community and other stakeholder views regarding the integration of TBAs into mental health care and promoting dialogue with the formal health sector. Various questionnaires will be administered at 0, 3, 6 and 9 months in order to test the effectiveness of the intervention at various intervals. Interviews will be conducted at 9 months for randomly selected mothers receiving the intervention and those in the control arm, for purposes of describing and evaluating their experiences regarding use of TBA and health care workers' services. The survival and physical wellbeing of the baby will also be measured using the labour process, birth and subsequent weight of the baby, completed schedules of immunization and developmental milestones until 6 months.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reduction in depressive symptoms
timeFrame: 0, 3, 6, and 9 months
Secondary outcomes:
measure: Intimate Partner violence
timeFrame: Baseline
measure: Quality of life of mothers with depression
timeFrame: 0, 3, 6, and 9 months
measure: Satisfaction levels
timeFrame: 0, 3, 6, and 9 months
measure: Suicidality
timeFrame: 0, 3, 6, and 9 months
measure: Disability
timeFrame: 0, 6, and 9 months
Other outcomes:
Locations:
city: Makueni
country: Kenya
facility: Tawa and Kanzokea
Study officials:
affiliation: Africa Mental Health Foundation
name: Christine W Musyimi
role: PRINCIPAL_INVESTIGATOR
References: