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

NCT06990802 | Not Yet Recruiting DMC

• 1 other identifier: 0000-0001-5034-0335g
• Study Type: interventional
• Target: 432
• Locations: 0 countries
• Sites: N/A

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

Conditions

Postnatal Depression; Child Health

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in postnatal depression is being assessed

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

  Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention

Secondary Outcomes (7)

• Change in postnatal anxiety is being assessed

  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

  Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention

• Change in social support is being assessed

  Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention

• Change in service satisfaction is being assessed

  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

  Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention

Study Arms (2)

LTP+CaCBT and TAU

EXPERIMENTAL

The LTP+CaCBT comprises 12 in-person sessions (90 minutes each) of intervention, which is the recommended duration for psychological interventions. LTP+CaCBT is manualised, and sessions will be delivered 'in-person' by non-specialist Community Health Workers (CHWs) in Nigeria. The CHWs will be trained to deliver the LTP+CaCBT under the supervision of Nigerian clinical psychologists and psychiatrists on a weekly basis. The proposed project adopts the World Health Organisation's (WHO) recommendations of task-shifting strategies to use non-specialists to tackle shortages of culturally knowledgeable mental health workforce in LMiCs, hence using CHWs. The experimental group will also receive Treatment As Usual (TAU). This includes participating services' regular treatment routine for postnatal depression. This is a standard patient care pathway, such as the service providers' routine assessment, management, and antidepressant prescriptions.

Behavioral: Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT); Drug: Treatment as Usual (TAU)

TAU alone

ACTIVE COMPARATOR

Treatment As Usual (TAU) alone group will receive the participating services' regular treatment routine for postnatal depression. This is a standard patient care pathway, such as the service providers' routine assessment, management, and antidepressant prescriptions which is entirely different from LTP+CaCBT.

Drug: Treatment as Usual (TAU)

Interventions

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.

LTP+CaCBT and TAU

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).

LTP+CaCBT and TAU; TAU alone

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Female participants - mothers of children between the ages of 0 and 3 years suffering from postnatal depression as a result of childbirth and parenting.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham Trent University: lead
• Coal City University, Nigeria: collaborator
• Jos University Teaching Hospital, Nigeria: collaborator
• Federal Medical Center, Abuja, Nigeria: collaborator

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Dung Jidong, PhD

CONTACT

+44 161 275 0813; dung.jidong@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: May 25, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share