Postnatal DepressionLTP+CaCBTNCT04644081
LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria
A study testing LTP, CaCBT and TAU in people with Postnatal Depression, run by Nottingham Trent University.
Trial summary
The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- LTP, CaCBT and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- Women only
- Healthy volunteers accepted
- 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 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS).
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
- Non-residents of Jos and environs
- Unable to consent
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- Patients currently undergoing severe mental health treatment
- Unable to speak English language fluently
- Other significant physical or learning disability
About this study
Official title: Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria: A Pilot Randomised Control Trial
The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.
Read the detailed description
Participants who scored 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS) would be recruited randomly assigned into two groups in each of the four primary health care (PHC) facilities designated for the present study. Groups one will receive the LTP+CaCBT treatment - the intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes). Groups two will receive routine treatment as usual (TAU) currently available in the PHC facilities (e.g. antidepressants) in the selected communities. Each group will comprise of approximately 10 mother-child pairs.
- Conditions
- Postnatal Depression
- Being tested
- LTP, CaCBT, TAU
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTPBehavioural
Also called Learning Through Play
LTP is a low-literacy, sustainable programme that will provide depressed mothers with valuable skills on parenting, improve mother-child relation and mental health self-care. This is a research-based activity that enhances postpartum mental health while simultaneously promoting attachment security through building parents' ability to monitor and be sensitive to their children's cues, and thereby, actively involves in their children's mental and physical development.
CaCBTBehavioural
Also called Cultural adapted Cognitive and Behaviour Therapy
CaCBT adopts 'here and now' problem-solving approach, which involves collaborating with families, active listening techniques, changing negative thinking, and depressive symptoms associated with postnatal depression and other forms of parenting distress.
TAUDrug
Also called Treatment as Usual
TAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of mental health care).
| Study group | Role | What they receive |
|---|---|---|
| LTP+CaCBT | Experimental | The LTP+CaCBT intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes) and will deliver two sessions on a weekly basis for six weeks. Receives: Behavioral: LTP; Behavioral: CaCBT |
| Treatment as Usual (TAU) | Active comparator | TAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of counselling services). Receives: Drug: 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 Edinburgh Postnatal Depression Scale
Measured: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Change in postnatal anxiety is being assessed
Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Measured: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Change in health 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 6 weeks and at 12 weeks post-intervention
Change in social support is being assessed
Primary outcome measures would be assessed using the Oslo Social Support Scale
Measured: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks post-intervention
Change in parenting knowledge of child development is being assessed
Outcome measure would be assessed using the Knowledge of Expectation and Child Development Questionnaire
Measured: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks 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 Nov 2020
- Study start1 Sep 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Teesside University, Sheffield Hallam University, University of Jos
- Responsible party
- Principal investigator, Dr Dung Jidong, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644081
- Sponsor's protocol ID
- 0000-0001-5034-0335
- Acronym
- LTP+CaCBT
- Status last verified
- Mar 2021
- First submitted
- 29 Oct 2020
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jidong DE, Ike TJ, Taru MY, Pwajok JY, Nwoga CN, Jidong JE, Francis C, Mwankon SB, Haruna K, Dagona Z, Husain N. A multi-centred pilot randomised controlled trial of learning through play plus culturally adapted cognitive behaviour therapy for treating postnatal depression in Nigerian women. Front Psychiatry. 2025 May 5;16:1552406. doi: 10.3389/fpsyt.2025.1552406. eCollection 2025.
PubMed 40391291
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria: A Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04644081
- Acronym / sponsor ID
- LTP+CaCBT / 0000-0001-5034-0335
- Conditions
- Postnatal Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- University of Manchester, Teesside University, Sheffield Hallam University, University of Jos
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 25 Nov 2020 (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.
The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.
Detailed description
Participants who scored 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS) would be recruited randomly assigned into two groups in each of the four primary health care (PHC) facilities designated for the present study. Groups one will receive the LTP+CaCBT treatment - the intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes). Groups two will receive routine treatment as usual (TAU) currently available in the PHC facilities (e.g. antidepressants) in the selected communities. Each group will comprise of approximately 10 mother-child pairs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTP+CaCBT | Experimental | Behavioral: LTP, Behavioral: CaCBTThe LTP+CaCBT intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes) and will deliver two sessions on a weekly basis for six weeks. |
| Treatment as Usual (TAU) | Active comparator | Drug: TAUTAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of counselling services). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 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
- Non-residents of Jos and environs
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 |
|---|---|---|
| LTPAlso: Learning Through PlayLTP is a low-literacy, sustainable programme that will provide depressed mothers with valuable skills on parenting, improve mother-child relation and mental health self-care. This is a research-based activity that enhances postpartum mental health while simultaneously promoting attachment security through building parents' ability to monitor and be sensitive to their children's cues, and thereby, actively involves in their children's mental and physical development. | Behavioural | LTP+CaCBT |
| CaCBTAlso: Cultural adapted Cognitive and Behaviour TherapyCaCBT adopts 'here and now' problem-solving approach, which involves collaborating with families, active listening techniques, changing negative thinking, and depressive symptoms associated with postnatal depression and other forms of parenting distress. | Behavioural | LTP+CaCBT |
| TAUAlso: Treatment as UsualTAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of mental health care). | Drug | Treatment as Usual (TAU) |
Primary outcome
Change in postnatal depression is being assessed
Time frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
Change in postnatal anxiety is being assessed
Time frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Change in health is being assessed
Time frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Change in social support is being assessed
Time frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measures would be assessed using the Oslo Social Support Scale
Change in health-related quality of life is being assessed
Time frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Change in service satisfaction is being assessed
Time frame: Change is being assessed at end of intervention at 6 weeks and at 12 weeks post-intervention
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Change in child physio-emotional development is being assessed
Time frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Change in parenting knowledge of child development is being assessed
Time frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Outcome measure would be assessed using the Knowledge of Expectation and Child Development Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Derived from this study: PubMed 40391291Jidong DE, Ike TJ, Taru MY, Pwajok JY, Nwoga CN, Jidong JE, Francis C, Mwankon SB, Haruna K, Dagona Z, Husain N. A multi-centred pilot randomised controlled trial of learning through play plus culturally adapted cognitive behaviour therapy for treating postnatal depression in Nigerian women. Front Psychiatry. 2025 May 5;16:1552406. doi: 10.3389/fpsyt.2025.1552406. eCollection 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LTP, CaCBT and TAU in people with Postnatal Depression, 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 6 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 6 weeks and at 12 weeks post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04644081, which also lists 1 linked publication.
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 Mar 2021.