Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage

NCT04820920 | Unknown DMC

• 1 other identifier: 0000-0001-5034-0335a
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK.

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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months 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 3-months and at 6-months post-intervention

• Change in parenting knowledge of child development is being assessed

  Outcome measure would be assessed using the Learning through Play (LTP) Knowledge, Attitude and Practices (KAP) Questionnaire

  Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention

Study Arms (2)

LTP+CaCBT

EXPERIMENTAL

The LTP+CaCBT intervention will consist of 10 (mother-child pairs) participants per sub-group in online group sessions (approx. 60 minutes each) and will deliver one session every fortnight for 12 sessions.

Behavioral: LTP; Behavioral: CaCBT

Psychoeducation

ACTIVE COMPARATOR

This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. The psychoeducation would last approximately 60 minutes each for 12 sessions (10 participants per sub-group). One session would be delivered every fortnight for 12 sessions.

Behavioral: Psychoeducation

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 postnatal 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

Psychoeducation BEHAVIORAL

This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years and above
• A mother with a child (0-3 years) from the African and/or Caribbean heritage
• Able to provide full consent for their participation
• A resident of the UK
• Able to complete a baseline assessment
• Score 5 or above on Patient Health Questionnaire (PHQ-9)

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 the UK
• Unable to consent
• Patients currently undergoing severe mental health treatment
• Unable to speak the 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

Study Sites (1)

Nottingham Trent University

Nottingham, England, NG1 4FQ, United Kingdom

RECRUITING

Related Publications (2)

• Jidong DE, Ike TJ, Murshed M, Francis C, Mwankon SB, Jidong JE, Pwajok JY, Nyam PP, Husain N. Postnatal depression in British mothers of African and Caribbean origin: a randomised controlled trial of learning through play plus culturally adapted cognitive behaviour therapy compared with psychoeducation. Front Psychiatry. 2024 Mar 28;15:1383990. doi: 10.3389/fpsyt.2024.1383990. eCollection 2024.

  PMID: 38606412 DERIVED

• Jidong DE, Ike JT, Husain N, Murshed M, Francis C, Mwankon BS, Jack BD, Jidong JE, Pwajok YJ, Nyam PP, Kiran T, Bassett P. Culturally adapted psychological intervention for treating maternal depression in British mothers of African and Caribbean origin: A randomized controlled feasibility trial. Clin Psychol Psychother. 2023 May-Jun;30(3):548-565. doi: 10.1002/cpp.2807. Epub 2023 Jan 3.

  PMID: 36478339 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Behavior Therapy

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

Central Study Contacts

Dung Jidong, PhD

CONTACT

115 84 86478; dung.jidong@ntu.ac.uk

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

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: September 14, 2021
• Primary Completion: April 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GB (1)