Clinical trial NCT04644081: LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria
Official title: Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria: A Pilot Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postnatal Depression
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Teesside University
name: Sheffield Hallam University
name: University of Jos
First posted: 2020-11-25
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in postnatal depression is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
measure: Change in postnatal anxiety is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
measure: Change in health is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
measure: Change in social support is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
measure: Change in health-related quality of life is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
measure: Change in service satisfaction is being assessed
timeFrame: Change is being assessed at end of intervention at 6 weeks and at 12 weeks post-intervention
measure: Change in child physio-emotional development is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
measure: Change in parenting knowledge of child development is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Secondary outcomes:
Other outcomes:
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