About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT)
BehavioralLTP+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.
Treatment as Usual (TAU)
DrugTAU 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).
Treatment groups
Trial outcomes
Primary outcomes
Change in postnatal depression is being assessed
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Secondary outcomes
Change in postnatal anxiety is being assessed
Secondary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Change in health-related quality of life is being assessed
Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Change in social support is being assessed
Outcome measures would be assessed using the Oslo Social Support Scale
Change in service satisfaction is being assessed
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Locations
Sponsors and contacts
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Nottingham Trent University
Lead sponsor
University of Manchester
Sponsor institution
Coal City University, Nigeria
Collaborator
Jos University Teaching Hospital, Nigeria
Collaborator
Federal Medical Center, Abuja, Nigeria
Collaborator
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