LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria

Nottingham Trent University

Status: Unknown

Conditions: Postnatal Depression

Treatments: Behavioral: CaCBT; Behavioral: LTP; Drug: TAU

Study type: Interventional

Funder types: Other

Identifiers

NCT04644081

0000-0001-5034-0335

Details and patient eligibility

About

The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.

Full description

Participants who scored 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS) would be recruited randomly assigned into two groups in each of the four primary health care (PHC) facilities designated for the present study. Groups one will receive the LTP+CaCBT treatment - the intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes). Groups two will receive routine treatment as usual (TAU) currently available in the PHC facilities (e.g. antidepressants) in the selected communities. Each group will comprise of approximately 10 mother-child pairs.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years and above
• A mother with a child (0-3 years)
• Able to provide full consent for their participation
• A resident of the trial catchment areas
• Able to complete a baseline assessment
• Score 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS).

Exclusion criteria

• Less than 18 years
• Medical disorder that would prevent participation in a clinical trial such as Tuberculosis or heart failure
• Temporary residents are unlikely to be available for follow up
• Active suicidal ideation or any other severe mental disorder
• Non-residents of Jos and environs
• Unable to consent
• Patients currently undergoing severe mental health treatment
• Unable to speak English language fluently
• Other significant physical or learning disability

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

LTP+CaCBT

Experimental group

Description:

The LTP+CaCBT intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes) and will deliver two sessions on a weekly basis for six weeks.

Treatment:

Behavioral: LTP

Behavioral: CaCBT

Treatment as Usual (TAU)

Active Comparator group

Description:

TAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of counselling services).

Treatment:

Drug: TAU