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Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria

Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06990802
Acronym
LTP+CaCBT
Enrollment
432
Registered
2025-05-25
Start date
2026-07-31
Completion date
2028-07-31
Last updated
2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Health, Postnatal Depression

Keywords

Postnatal depression, Child health, Intervention, Parenting, Childbirth, Maternal mental health

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

Interventions

BEHAVIORALLearning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT)

LTP+CaCBT has two components. LTP is underpinned by Piaget's theory of cognitive development and Bowlby's theory of attachment. The CBT component uses active listening techniques, changing negative thinking, and guided discovery (i.e., Socratic questioning style to gently probe for cultural beliefs on mental health and stimulate alternative positive thinking). This includes a culturally adapted pictorial calendar devised for women, depicting successive stages of child well-being from 0-3 years, with illustrations of mother-child play and other culturally relevant activities that promote healthy parenting and mother-child attachment.

DRUGTreatment as Usual (TAU)

TAU is the routine care currently available for the treatment of postnatal depression at the health care sites of intervention (e.g. diagnosis, management, antidepressant prescription and/or other forms of mental health care).

Sponsors

Coal City University, Nigeria
CollaboratorUNKNOWN
Jos University Teaching Hospital, Nigeria
CollaboratorUNKNOWN
Federal Medical Center, Abuja, Nigeria
CollaboratorUNKNOWN
Nottingham Trent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in postnatal depression is being assessedChange is being assessed from baseline, end of intervention at 4 and at 6 months post-interventionPrimary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)

Secondary

MeasureTime frameDescription
Change in postnatal anxiety is being assessedChange is being assessed from baseline, end of intervention at 4 and at 6 months post-interventionSecondary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Change in health-related quality of life is being assessedChange is being assessed from baseline, end of intervention at 4 and at 6 months post-interventionOutcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Change in service satisfaction is being assessedChange is being assessed from baseline, end of intervention at 4 and 6 months post-interventionOutcome measure would be assessed using the brief Verona Service Satisfaction Scale
Change in child physio-emotional development is being assessedChange is being assessed from baseline, end of intervention at 4 and 6 months post-interventionOutcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Change in mother-child attachedment is being assessedChange is being assessed from baseline, end of intervention at 4 and 6 months post-interventionOutcome measures would be assessed using the Maternal Attachment Inventory
Change in social support is being assessedChange is being assessed from baseline, end of intervention at 4 and 6 months post-interventionOutcome measures would be assessed using the Oslo Social Support Scale

Contacts

Primary ContactDung Jidong, PhD
dung.jidong@manchester.ac.uk+44 161 275 0813

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026