Postnatal DepressionLTP+CaCBTNCT06990802
Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria
A study testing Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT) and Treatment as Usual (TAU) in people with Postnatal Depression and Child Health, run by Nottingham Trent University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Postnatal Depression, Child Health
- What is being tested?
- Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Unable to consent
- Unable to speak and understand English language
- Other significant physical or learning disability
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT), Treatment as Usual (TAU)
- Keywords
- Postnatal depression, Child health, Intervention, Parenting, Childbirth, Maternal mental health
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT)Behavioural
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postnatal depression is being assessed
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Measured: 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
Secondary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Measured: 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
Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Measured: Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention
Change in social support is being assessed
Outcome measures would be assessed using the Oslo Social Support Scale
Measured: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention
Change in service satisfaction is being assessed
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Measured: 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
Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Measured: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention
Change in mother-child attachedment is being assessed
Outcome measures would be assessed using the Maternal Attachment Inventory
Measured: Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention
Change in service satisfaction is being assessed
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Measured: Change is being assessed at end of intervention at 4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startJul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- Coal City University, Nigeria, Jos University Teaching Hospital, Nigeria, Federal Medical Center, Abuja, Nigeria
- Responsible party
- Principal investigator, Dr Dung Jidong, PhD, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990802
- Sponsor's protocol ID
- 0000-0001-5034-0335g
- Acronym
- LTP+CaCBT
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria
- ClinicalTrials.gov ID
- NCT06990802
- Acronym / sponsor ID
- LTP+CaCBT / 0000-0001-5034-0335g
- Conditions
- Postnatal Depression, Child Health
- Keywords
- Postnatal depression, Child health, Intervention, Parenting, Childbirth, Maternal mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- Coal City University, Nigeria, Jos University Teaching Hospital, Nigeria, Federal Medical Center, Abuja, Nigeria
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTP+CaCBT and TAU | Experimental | Behavioral: Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT), Drug: Treatment as Usual (TAU)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. |
| TAU alone | Active comparator | Drug: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, with illustrations of mother-child play and other culturally relevant activities that promote healthy parenting and mother-child attachment. | Behavioural | LTP+CaCBT and TAU |
| 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). | Drug | LTP+CaCBT and TAU, TAU alone |
Primary outcome
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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
Related trials for Postnatal Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT) and Treatment as Usual (TAU) in people with Postnatal Depression and Child Health, run by Nottingham Trent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dung Jidong, PhD (+44 161 275 0813, dung.jidong@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.