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

NCT ID: NCT04644081

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-12-30

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.

Conditions

Postnatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

LTP

Intervention Type: BEHAVIORAL

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.

CaCBT

Intervention Type: BEHAVIORAL

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.

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).

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: DRUG

Other Intervention Names

Learning Through Play; Cultural adapted Cognitive and Behaviour Therapy; Treatment as Usual

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Teesside University

OTHER

Sponsor Role: collaborator

Sheffield Hallam University

OTHER

Sponsor Role: collaborator

University of Jos

UNKNOWN

Sponsor Role: collaborator

Nottingham Trent University

OTHER

Sponsor Role: lead

Responsible Party

Dr Dung Jidong

Senior Lecturer/Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Jidong DE, Ike TJ, Taru MY, Pwajok JY, Nwoga CN, Jidong JE, Francis C, Mwankon SB, Haruna K, Dagona Z, Husain N. A multi-centred pilot randomised controlled trial of learning through play plus culturally adapted cognitive behaviour therapy for treating postnatal depression in Nigerian women. Front Psychiatry. 2025 May 5;16:1552406. doi: 10.3389/fpsyt.2025.1552406. eCollection 2025.

Reference Type: DERIVED

PMID: 40391291 (View on PubMed)

Other Identifiers

0000-0001-5034-0335

Identifier Type: -

Identifier Source: org_study_id