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

November 22, 2021 updated by: Dr Dung Jidong, PhD, Nottingham Trent University

Online Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy (LTP+CaCBT) for Treating Depression in British Mothers of African and Caribbean Heritage: A Pilot Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants who scored 5 or above on Patient Health Questionnaire (PHQ-9) will be would be recruited and randomly assigned into one of two groups (experimental or controlled). Experimental groups will receive the online LTP+CaCBT treatment - the intervention will consist of a total of 12 group training sessions (approx. 60 minutes each). The controlled groups will receive 'placebo effects' in the form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions. Each of the two groups (both experimental and controlled) will be comprised of approximately 10 mother-child pairs per sub-group.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • England
      • Nottingham, England, United Kingdom, NG1 4FQ
        • Recruiting
        • Nottingham Trent University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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) 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)

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LTP+CaCBT
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
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.
Other Names:
  • Learning Through Play
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
Active Comparator: Psychoeducation
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
This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postnatal depression is being assessed
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
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
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
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
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
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
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
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
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
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
Time Frame: Change is being assessed at end of intervention, at 3-months and at 6-months post-intervention
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
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
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
Time Frame: Change is being assessed from baseline, end of intervention, at 3-months and at 6-months post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham Trent University

Collaborators

Sheffield Hallam University
University of Manchester
Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2021

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-0001-5034-0335a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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