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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04820920
Enrollment
120
Registered
2021-03-29
Start date
2021-09-14
Completion date
2023-08-30
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal Depression

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.

Interventions

BEHAVIORALLTP

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.

BEHAVIORALCaCBT

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.

BEHAVIORALPsychoeducation

This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.

Sponsors

University of Manchester
CollaboratorOTHER
Teesside University
CollaboratorOTHER
Sheffield Hallam University
CollaboratorOTHER
Nottingham Trent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in postnatal depression is being assessedChange is being assessed from baseline, end of intervention, at 3-months and at 6-months post-interventionPrimary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
Change in postnatal anxiety is being assessedChange is being assessed from baseline, end of intervention, at 3-months and at 6-months post-interventionPrimary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Change in health is being assessedChange is being assessed from baseline, end of intervention, at 3-months and at 6-months post-interventionPrimary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Change in social support is being assessedChange is being assessed from baseline, end of intervention, at 3-months and at 6-months post-interventionPrimary outcome measures would be assessed using the Oslo Social Support Scale
Change in health-related quality of life is being assessedChange is being assessed from baseline, end of intervention, at 3-months and at 6-months post-interventionOutcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Change in service satisfaction is being assessedChange is being assessed at end of intervention, at 3-months and at 6-months post-interventionOutcome measure would be assessed using the brief Verona Service Satisfaction Scale
Change in child physio-emotional development is being assessedChange is being assessed from baseline, end of intervention, at 3-months and at 6-months post-interventionOutcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Change in parenting knowledge of child development is being assessedChange is being assessed from baseline, end of intervention, at 3-months and at 6-months post-interventionOutcome measure would be assessed using the Learning through Play (LTP) Knowledge, Attitude and Practices (KAP) Questionnaire

Countries

United Kingdom

Contacts

Primary ContactDung Jidong, PhD
dung.jidong@ntu.ac.uk115 84 86478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026