Clinical trial NCT04820920: Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postnatal Depression
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Teesside University
name: Sheffield Hallam University
First posted: 2021-03-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in postnatal depression is being assessed
timeFrame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
measure: Change in postnatal anxiety is being assessed
timeFrame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
measure: Change in health is being assessed
timeFrame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
measure: Change in social support is being assessed
timeFrame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
measure: Change in health-related quality of life is being assessed
timeFrame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
measure: Change in service satisfaction is being assessed
timeFrame: Change is being assessed at end of intervention, at 3-months and at 6-months post-intervention
measure: Change in child physio-emotional development is being assessed
timeFrame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
measure: Change in parenting knowledge of child development is being assessed
timeFrame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Trent University
state: England
Study officials:
References: