Engaging Traditional Birth Attendants to Reduce Maternal Depression in Rural Kenya (ENGAGE-TBA)

Africa Institute of Mental and Brain Health (AFRIMEB)

Status: Completed

Conditions: Depression

Treatments: Behavioral: mhGAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03378544

AfricaMHF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Experimental arm

Experimental group

Description:

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.

Treatment:

Behavioral: mhGAP

Control group

No Intervention group

Description:

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