Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage
- Conditions
- Postnatal Depression
- Interventions
- Behavioral: LTPBehavioral: PsychoeducationBehavioral: CaCBT
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- 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)
- 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
- Arm && Interventions
Group Intervention Description LTP+CaCBT CaCBT 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. LTP+CaCBT LTP 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. Psychoeducation Psychoeducation 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.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nottingham Trent University
🇬🇧Nottingham, England, United Kingdom