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

Not Applicable

• Conditions: Postnatal Depression

• Registration Number: NCT04820920
• Lead Sponsor: Nottingham Trent University

Brief 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.

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 Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Study Start: 2021-09-14
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-24
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in postnatal depression is being assessed	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	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	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	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	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	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	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	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

Trial Locations

Locations (1)

Nottingham Trent University; 🇬🇧 Nottingham, England, United Kingdom