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

NCT ID: NCT04820920

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postnatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

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 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.

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.

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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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.

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

Psychoeducation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Learning Through Play Cultural adapted Cognitive and Behaviour Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

Teesside University

OTHER

Sponsor Role collaborator

Sheffield Hallam University

OTHER

Sponsor Role collaborator

Nottingham Trent University

OTHER

Sponsor Role lead

Responsible Party

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Dr Dung Jidong, PhD

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nottingham Trent University

Nottingham, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dung Jidong, PhD

Role: CONTACT

Phone: 115 84 86478

Email: [email protected]

Facility Contacts

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Dung Jidong, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38606412 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36478339 (View on PubMed)

Other Identifiers

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0000-0001-5034-0335a

Identifier Type: -

Identifier Source: org_study_id