Clinical trial NCT06990802: Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria
Official title: Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postnatal Depression
Child Health
Keywords: Postnatal depression
Child health
Intervention
Parenting
Childbirth
Maternal mental health
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: Coal City University, Nigeria
name: Jos University Teaching Hospital, Nigeria
name: Federal Medical Center, Abuja, Nigeria
First posted: 2025-05-25
Enrollment: 432
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: We aim to examine the effectiveness of Learning Through Play and Cognitive Behaviour Therapy (LTP+CaCBT), a culturally appropriate psychosocial intervention to address postnatal depression among Nigerian women and improve the well-being of their children. Women of reproductive age (ages 16 to 49) comprise about 60 million of Nigeria's 230 million people. About 30% of these mothers experience postnatal depression. The global health challenge our research addresses is that one in three women worldwide experience postnatal depression and suicidal thoughts after childbirth, with long-term negative consequences on their children and families. Since 30% of Nigerian mothers suffer from postnatal depression, they have significant risks of transferring intergenerational mental health problems to their children. Over 250 million children are at risk of lacking developmental support in low- or middle-income countries, including Nigeria, due to postnatal depression, and this limits the children from reaching their full potential in life. The treatment gap for postnatal depression in Nigeria is huge due to a shortage of mental health specialists. Culturally appropriate, nonspecialist-delivered interventions are very limited in Nigeria. Our proposal aims to address this gap in treating postnatal depression using non-specialists called Indigenous Community Health Workers (CHWs), who are more culturally knowledgeable, as the World Health Organisation recommended in their task-shifting strategy.

Methods: We will evaluate the treatment, costs and implementation outcomes of LTP+CaCBT with 432 depressed mothers. Eligible participants (mother-child pairs) will be randomly selected to receive LTP+CaCBT and Treatment As Usual (TAU) or TAU alone. Our LTP+CaCBT intervention is a manualised 12-session (90-minute each) of mother-child play activities delivered in-person by CHWs under the supervision of clinical psychologists/psychiatrists. The eligible mothers (aged 16-49 years who have children between ages 0-36 months) will be assessed for depression before the intervention and then again at 4 months and 6 months afterwards. We will conduct interviews and focus group discussions to understand participants' and CHWs' experiences of the intervention


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 5 or above on Patient Health Questionnaire (PHQ-9)
* available for follow-up at 4 and 6 months post-enrolment

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
* Patients currently undergoing severe mental health treatment
* Non-residents of the trial environs
* Unable to consent
* Unable to speak and understand English language
* 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 4 and at 6 months post-intervention
Secondary outcomes:
measure: Change in postnatal anxiety is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention
measure: Change in health-related quality of life is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention
measure: Change in social support is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention
measure: Change in service satisfaction is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention
measure: Change in child physio-emotional development is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention
measure: Change in mother-child attachedment is being assessed
timeFrame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention
measure: Change in service satisfaction is being assessed
timeFrame: Change is being assessed at end of intervention at 4 months post-intervention
Other outcomes:
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