Postnatal DepressionNCT04820920
Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage
A study testing LTP, CaCBT and Psychoeducation in people with Postnatal Depression, run by Nottingham Trent University at 1 site in United Kingdom.
Trial summary
The pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- LTP, CaCBT and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2021to 30 Aug 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 18 years and above
- A mother with a child (0-3 years) from the African and/or Caribbean heritage
- Able to provide full consent for their participation
- A resident of the UK
- Able to complete a baseline assessment
- Score 5 or above on Patient Health Questionnaire (PHQ-9)
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 the UK
- Unable to consent
Show all 9Show fewer
- Patients currently undergoing severe mental health treatment
- Unable to speak the English language fluently
- Other significant physical or learning disability
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham Trent University
Nottingham, England, NG1 4FQ
Dung Jidong, PhD, 115 84 86478 ext. +44, dung.jidong@ntu.ac.uk
About this study
Official title: Online Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy (LTP+CaCBT) for Treating Depression in British Mothers of African and Caribbean Heritage: A Pilot Randomised Controlled Trial
The pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK.
Read the detailed description
Participants who scored 5 or above on Patient Health Questionnaire (PHQ-9) will be would be recruited and randomly assigned into one of two groups (experimental or controlled). Experimental groups will receive the online LTP+CaCBT treatment - the intervention will consist of a total of 12 group training sessions (approx. 60 minutes each). The controlled groups will receive 'placebo effects' in the form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. Each of the two groups (both experimental and controlled) will be comprised of approximately 10 mother-child pairs per sub-group.
- Conditions
- Postnatal Depression
- Being tested
- LTP, CaCBT, Psychoeducation
- 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 postnatal 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.
PsychoeducationBehavioural
This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.
| Study group | Role | What they receive |
|---|---|---|
| LTP+CaCBT | Experimental | The LTP+CaCBT intervention will consist of 10 (mother-child pairs) participants per sub-group in online group sessions (approx. 60 minutes each) and will deliver one session every fortnight for 12 sessions. Receives: Behavioral: LTP; Behavioral: CaCBT |
| Psychoeducation | Active comparator | This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. The psychoeducation would last approximately 60 minutes each for 12 sessions (10 participants per sub-group). One session would be delivered every fortnight for 12 sessions. Receives: Behavioral: Psychoeducation |
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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months 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 3-months and at 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 3-months and at 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 3-months and at 6-months post-intervention
Change in parenting knowledge of child development is being assessed
Outcome measure would be assessed using the Learning through Play (LTP) Knowledge, Attitude and Practices (KAP) Questionnaire
Measured: Change is being assessed from baseline, end of intervention, at 3-months and at 6-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 posted29 Mar 2021
- Study start14 Sep 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 120 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
- Responsible party
- Principal investigator, Dr Dung Jidong, PhD, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820920
- Sponsor's protocol ID
- 0000-0001-5034-0335a
- Status last verified
- Nov 2021
- First submitted
- 24 Mar 2021
- Last updated
- 24 Nov 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, Murshed M, Francis C, Mwankon SB, Jidong JE, Pwajok JY, Nyam PP, Husain N. Postnatal depression in British mothers of African and Caribbean origin: a randomised controlled trial of learning through play plus culturally adapted cognitive behaviour therapy compared with psychoeducation. Front Psychiatry. 2024 Mar 28;15:1383990. doi: 10.3389/fpsyt.2024.1383990. eCollection 2024.
PubMed 38606412Jidong DE, Ike JT, Husain N, Murshed M, Francis C, Mwankon BS, Jack BD, Jidong JE, Pwajok YJ, Nyam PP, Kiran T, Bassett P. Culturally adapted psychological intervention for treating maternal depression in British mothers of African and Caribbean origin: A randomized controlled feasibility trial. Clin Psychol Psychother. 2023 May-Jun;30(3):548-565. doi: 10.1002/cpp.2807. Epub 2023 Jan 3.
PubMed 36478339
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy (LTP+CaCBT) for Treating Depression in British Mothers of African and Caribbean Heritage: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04820920
- Acronym / sponsor ID
- 0000-0001-5034-0335a
- Conditions
- Postnatal Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- University of Manchester, Teesside University, Sheffield Hallam University
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 29 Mar 2021 (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 pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK.
Detailed description
Participants who scored 5 or above on Patient Health Questionnaire (PHQ-9) will be would be recruited and randomly assigned into one of two groups (experimental or controlled). Experimental groups will receive the online LTP+CaCBT treatment - the intervention will consist of a total of 12 group training sessions (approx. 60 minutes each). The controlled groups will receive 'placebo effects' in the form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. Each of the two groups (both experimental and controlled) will be comprised of approximately 10 mother-child pairs per sub-group.
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 10 (mother-child pairs) participants per sub-group in online group sessions (approx. 60 minutes each) and will deliver one session every fortnight for 12 sessions. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationThis is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. The psychoeducation would last approximately 60 minutes each for 12 sessions (10 participants per sub-group). One session would be delivered every fortnight for 12 sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years and above
- A mother with a child (0-3 years) from the African and/or Caribbean heritage
- Able to provide full consent for their participation
- A resident of the UK
- 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 the UK
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 postnatal 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 |
| PsychoeducationThis is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. | Behavioural | Psychoeducation |
Primary outcome
Change in postnatal depression is being assessed
Time frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months post-intervention
Outcome measure would be assessed using the Learning through Play (LTP) Knowledge, Attitude and Practices (KAP) Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Derived from this study: PubMed 38606412Jidong DE, Ike TJ, Murshed M, Francis C, Mwankon SB, Jidong JE, Pwajok JY, Nyam PP, Husain N. Postnatal depression in British mothers of African and Caribbean origin: a randomised controlled trial of learning through play plus culturally adapted cognitive behaviour therapy compared with psychoeducation. Front Psychiatry. 2024 Mar 28;15:1383990. doi: 10.3389/fpsyt.2024.1383990. eCollection 2024.
- Derived from this study: PubMed 36478339Jidong DE, Ike JT, Husain N, Murshed M, Francis C, Mwankon BS, Jack BD, Jidong JE, Pwajok YJ, Nyam PP, Kiran T, Bassett P. Culturally adapted psychological intervention for treating maternal depression in British mothers of African and Caribbean origin: A randomized controlled feasibility trial. Clin Psychol Psychother. 2023 May-Jun;30(3):548-565. doi: 10.1002/cpp.2807. Epub 2023 Jan 3.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTP, CaCBT and Psychoeducation in people with Postnatal Depression, run by Nottingham Trent University at 1 site in United Kingdom.
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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Dung Jidong, PhD (115 84 86478 ext. +44, dung.jidong@ntu.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 3-months and at 6-months 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 NCT04820920, which also lists 2 linked publications.
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 24 Nov 2021.