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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postnatal Depression

Intervention / Treatment
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* Behavioral: LTP
* Behavioral: CaCBT
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTP+CaCBT<br>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. | Behavioral: LTP<br>* 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.<br>* Other names: Learning Through Play;Behavioral: CaCBT<br>* 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.<br>* Other names: Cultural adapted Cognitive and Behaviour Therapy;|
| Active Comparator: Psychoeducation<br>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. | Behavioral: Psychoeducation<br>* This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |