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NCT Number: NCT06990802

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

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

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Key information

Conditions

Postnatal Depression Child Health Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Treatment as Usual (TAU)

Drug

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 outcomes

  1. 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

    Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)

Secondary outcomes

  1. 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

    Secondary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale

  2. 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

    Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)

  3. 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

    Outcome measures would be assessed using the Oslo Social Support Scale

  4. 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

    Outcome measure would be assessed using the brief Verona Service Satisfaction Scale

  5. 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

    Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire

  6. 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

    Outcome measures would be assessed using the Maternal Attachment Inventory

  7. Change in service satisfaction is being assessed

    Time frame: Change is being assessed at end of intervention at 4 months post-intervention

    Outcome measure would be assessed using the brief Verona Service Satisfaction Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Dung Jidong, PhD

CONTACT

[email protected]

+44 161 275 0813

Sponsors and collaborators

Lead sponsor

Nottingham Trent University

Other

Collaborators

  • Coal City University, Nigeria
  • Federal Medical Center, Abuja, Nigeria
  • Jos University Teaching Hospital, Nigeria

Registry information

Acronym: LTP+CaCBT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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