Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage

Postnatal Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820920
• Other study ID #: 0000-0001-5034-0335a
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: November 2021
• Source: Nottingham Trent University
• Contact: Dung Jidong, PhD
• Phone: 115 84 86478
• Email: dung.jidong[@]ntu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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)

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
• Non-residents of the UK
• Unable to consent
• Patients currently undergoing severe mental health treatment
• Unable to speak the English language fluently
• Other significant physical or learning disability

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

Behavioral:
• LTP
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.
• CaCBT
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.
• Psychoeducation
This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.

Locations

Country	Name	City	State
United Kingdom	Nottingham Trent University	Nottingham	England

Sponsors (4)

Lead Sponsor	Collaborator
Nottingham Trent University	Sheffield Hallam University, Teesside University, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postnatal depression is being assessed	Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale	Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary	Change in postnatal anxiety is being assessed	Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale	Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary	Change in health 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 3-months and at 6-months post-intervention
Primary	Change in social support is being assessed	Primary outcome measures would be assessed using the Oslo Social Support Scale	Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary	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)	Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary	Change in service satisfaction is being assessed	Outcome measure would be assessed using the brief Verona Service Satisfaction Scale	Change is being assessed at end of intervention, at 3-months and at 6-months post-intervention
Primary	Change in child physio-emotional development is being assessed	Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire	Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Primary	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	Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention