Back to resultsLTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria (LTP+CaCBT)
Primary Purpose
Postnatal Depression
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LTP
CaCBT
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Postnatal Depression
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LTP+CaCBT
Treatment as Usual (TAU)
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Change in postnatal depression is being assessed
Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
Change in postnatal anxiety is being assessed
Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Change in health is being assessed
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Change in social support is being assessed
Primary outcome measures would be assessed using the Oslo Social Support Scale
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 in service satisfaction is being assessed
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Change in child physio-emotional development is being assessed
Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Change in parenting knowledge of child development is being assessed
Outcome measure would be assessed using the Knowledge of Expectation and Child Development Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT04644081
First Posted
October 29, 2020
Last Updated
March 24, 2021
Sponsor
Nottingham Trent University
Collaborators
University of Manchester, Teesside University, Sheffield Hallam University, University of Jos
1. Study Identification
Unique Protocol Identification Number
NCT04644081
Brief Title
LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria
Acronym
LTP+CaCBT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nottingham Trent University
Collaborators
University of Manchester, Teesside University, Sheffield Hallam University, University of Jos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LTP+CaCBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
LTP
Other Intervention Name(s)
Learning Through Play
Intervention Description
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 postpartum 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.
Intervention Type
Behavioral
Intervention Name(s)
CaCBT
Other Intervention Name(s)
Cultural adapted Cognitive and Behaviour Therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TAU
Other Intervention Name(s)
Treatment as Usual
Intervention Description
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 mental health care).
Primary Outcome Measure Information:
Title
Change in postnatal depression is being assessed
Description
Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale
Time Frame
Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Title
Change in postnatal anxiety is being assessed
Description
Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale
Time Frame
Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Title
Change in health is being assessed
Description
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
Time Frame
Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Title
Change in social support is being assessed
Description
Primary outcome measures would be assessed using the Oslo Social Support Scale
Time Frame
Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Title
Change in health-related quality of life is being assessed
Description
Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)
Time Frame
Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Title
Change in service satisfaction is being assessed
Description
Outcome measure would be assessed using the brief Verona Service Satisfaction Scale
Time Frame
Change is being assessed at end of intervention at 6 weeks and at 12 weeks post-intervention
Title
Change in child physio-emotional development is being assessed
Description
Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire
Time Frame
Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
Title
Change in parenting knowledge of child development is being assessed
Description
Outcome measure would be assessed using the Knowledge of Expectation and Child Development Questionnaire
Time Frame
Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria
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