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

Overview

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

• Behavioral Learning 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,
• Drug Treatment 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).

Primary outcome measures

• Change in postnatal depression is being assessed [Time frame: Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention]

Secondary outcome measures (7)

• Change in postnatal anxiety is being assessed [Time frame: Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention]
• Change in health-related quality of life is being assessed [Time frame: Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention]
• Change in social support is being assessed [Time frame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention]
• Change in service satisfaction is being assessed [Time frame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention]
• Change in child physio-emotional development is being assessed [Time frame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention]
• Change in mother-child attachedment is being assessed [Time frame: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention]
• Change in service satisfaction is being assessed [Time frame: Change is being assessed at end of intervention at 4 months post-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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06990802 · 0000-0001-5034-0335g

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗