Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria: A Pilot Randomised Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nottingham Trent University
- Enrollment
- 90
- Primary Endpoint
- Change in postnatal anxiety is being assessed
Study Overview
Brief Summary
The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.
Detailed Description
Participants who scored 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS) would be recruited randomly assigned into two groups in each of the four primary health care (PHC) facilities designated for the present study. Groups one will receive the LTP+CaCBT treatment - the intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes). Groups two will receive routine treatment as usual (TAU) currently available in the PHC facilities (e.g. antidepressants) in the selected communities. Each group will comprise of approximately 10 mother-child pairs.
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
- Yes
Inclusion Criteria
- •18 years and above
- •A mother with a child (0-3 years)
- •Able to provide full consent for their participation
- •A resident of the trial catchment areas
- •Able to complete a baseline assessment
- •Score 10 or above on Patient Health Questionnaire (PHQ-9) and tested positive for postnatal depression on the Edinburgh Postnatal Depression Scale (EPDS).
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 Jos and environs
- •Unable to consent
- •Patients currently undergoing severe mental health treatment
- •Unable to speak English language fluently
- •Other significant physical or learning disability
Arms & Interventions
LTP+CaCBT
The LTP+CaCBT intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes) and will deliver two sessions on a weekly basis for six weeks.
Intervention: LTP (Behavioral)
LTP+CaCBT
The LTP+CaCBT intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes) and will deliver two sessions on a weekly basis for six weeks.
Intervention: CaCBT (Behavioral)
Treatment as Usual (TAU)
TAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of counselling services).
Intervention: TAU (Drug)
Outcomes
Primary Outcomes
Change in postnatal anxiety is being assessed
Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Change in postnatal depression is being assessed
Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
Change in social support is being assessed
Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measures would be assessed using the Oslo Social Support Scale
Change in service satisfaction is being assessed
Time Frame: Change is being assessed at end of intervention at 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks post-intervention
Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Change in health-related quality of life is being assessed
Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Change in health is being assessed
Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Change in parenting knowledge of child development is being assessed
Time Frame: Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Outcome measure would be assessed using the Knowledge of Expectation and Child Development Questionnaire
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Dung Jidong
Senior Lecturer/Lecturer
Nottingham Trent University