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

Nottingham Trent University

Status: Unknown

Conditions: Postnatal Depression

Treatments: Behavioral: CaCBT; Behavioral: LTP; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT04820920

0000-0001-5034-0335a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

LTP+CaCBT

Experimental group

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.

Treatment:

Behavioral: LTP

Behavioral: CaCBT

Psychoeducation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducation