LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria (LTP+CaCBT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postnatal Depression
• Intervention / Treatment: Behavioral: CaCBT; Behavioral: LTP; Drug: TAU

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: CaCBT; 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.; Other Names: Cultural adapted Cognitive and Behaviour Therapy; Behavioral: LTP; 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.; Other Names: Learning Through Play
Active Comparator: 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).	Drug: 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 mental health care).; Other Names: Treatment as Usual

What is the study measuring?

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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks 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 6 weeks and at 12 weeks post-intervention
Change in parenting knowledge of child development is being assessed	Outcome measure would be assessed using the Knowledge of Expectation and Child Development Questionnaire	Change is being assessed from baseline, end of intervention at 6 weeks and at 12 weeks post-intervention

Collaborators and Investigators

• Sponsor: Nottingham Trent University
• Collaborators: Sheffield Hallam University; University of Manchester; Teesside University; University of Jos

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 0000-0001-5034-0335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No