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

NCT04644081 | Unknown DMC

• 1 other identifier: 0000-0001-5034-0335
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postnatal Depression

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

LTP+CaCBT

EXPERIMENTAL

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: LTP; Behavioral: CaCBT

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Interventions

LTP 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.

Also known as: Learning Through Play

LTP+CaCBT

CaCBT 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.

Also known as: Cultural adapted Cognitive and Behaviour Therapy

LTP+CaCBT

TAU 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).

Also known as: Treatment as Usual

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham Trent University: lead
• University of Manchester: collaborator
• Teesside University: collaborator
• Sheffield Hallam University: collaborator
• University of Jos: collaborator

Related Publications (1)

• 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.

  PMID: 40391291 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Behavior Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer/Lecturer

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 25, 2020
• Study Start: September 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 30, 2022
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share