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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nottingham Trent University
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change in postnatal depression is being assessed
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Dung Jidong, PhD
Senior Lecturer
Nottingham Trent University