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

Primary Purpose

Postnatal Depression

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

LTP

CaCBT

Psychoeducation

About this trial

This is an interventional treatment trial for Postnatal Depression

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Nottingham Trent UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LTP+CaCBT

Psychoeducation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in postnatal depression is being assessed

Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale

Change in postnatal anxiety is being assessed

Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale

Change in health is being assessed

Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)

Change in social support is being assessed

Primary outcome measures would be assessed using the Oslo Social Support Scale

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 in service satisfaction is being assessed

Outcome measure would be assessed using the brief Verona Service Satisfaction Scale

Change in child physio-emotional development is being assessed

Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04820920

First Posted

March 24, 2021

Last Updated

November 22, 2021

Sponsor

Nottingham Trent University

Collaborators

University of Manchester, Teesside University, Sheffield Hallam University

1. Study Identification

Unique Protocol Identification Number

NCT04820920

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 14, 2021 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nottingham Trent University

Collaborators

University of Manchester, Teesside University, Sheffield Hallam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postnatal Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LTP+CaCBT

Arm Type

Experimental

Arm Description

Arm Title

Psychoeducation

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

LTP

Other Intervention Name(s)

Learning Through Play

Intervention Description

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

Intervention Name(s)

CaCBT

Other Intervention Name(s)

Cultural adapted Cognitive and Behaviour Therapy

Intervention Description

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

Intervention Name(s)

Psychoeducation

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in postnatal depression is being assessed

Description

Primary outcome measure would be assessed using the Edinburgh Postnatal Depression Scale

Time Frame

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

Title

Change in postnatal anxiety is being assessed

Description

Primary outcome measure would be assessed using the Generalised Anxiety Disorder (GAD7) scale

Time Frame

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

Title

Change in health is being assessed

Description

Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)

Time Frame

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

Title

Change in social support is being assessed

Description

Primary outcome measures would be assessed using the Oslo Social Support Scale

Time Frame

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

Title

Change in health-related quality of life is being assessed

Description

Outcome measure would be assessed using the Health-related Quality of Life scale (EuroQoL-5 Dimensions)

Time Frame

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

Title

Change in service satisfaction is being assessed

Description

Outcome measure would be assessed using the brief Verona Service Satisfaction Scale

Time Frame

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

Title

Change in child physio-emotional development is being assessed

Description

Outcome measure would be assessed using the Ages and Stages Social-Emotional Questionnaire

Time Frame

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

Title

Change in parenting knowledge of child development is being assessed

Description

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

Time Frame

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

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dung Jidong, PhD

Phone

115 84 86478

Ext

+44

dung.jidong@ntu.ac.uk

Facility Information:

Facility Name

Nottingham Trent University

City

Nottingham

State/Province

England

ZIP/Postal Code

NG1 4FQ

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dung Jidong, PhD

Phone

115 84 86478

Ext

+44

dung.jidong@ntu.ac.uk

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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