Enjoy Your Bump : Online Cognitive Behavioural Therapy in Pregnancy

NCT ID: NCT03373734

Last Updated: 2024-06-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2019-03-01

Brief Summary

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A feasibility study evaluating how acceptable women experiencing low mood or anxiety during their pregnancy find an online Cognitive Behavioural Therapy course called 'Enjoy Your Bump'. This project will also begin to explore the effectiveness of this programme as a low intensity self-help intervention for mild to moderate depressive symptoms during pregnancy.

Detailed Description

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'Enjoy Your Bump (EYB)' is an online life skills course based on Cognitive Behavioural Therapy (CBT) principles which has been designed to specifically support women in the antenatal period. A survey of women and health professionals has demonstrated that this is a resource that both groups find acceptable. The aim of this quasi-experimental feasibility study is to evaluate the user experience and efficacy of this online programme as a non-pharmacological, low intensity intervention for women experiencing mild-moderate depressive symptoms in pregnancy. This will be achieved by measuring depression and anxiety as well as measures of attachment to the developing baby, pre and post intervention. It is hoped the results from this study will help inform whether this is a resource that should be made more widely available to women in the National Health Service (NHS). It is hypothesised that the 'Enjoy Your Bump' will be an acceptable and effective intervention for women experiencing mild to moderate depressive symptoms in the antenatal period.

Conditions

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Perinatal Mental Health Antenatal Depression Antenatal Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Enjoy Your Bump is an online life skills course based on cognitive behavioural therapy principles. It has been designed to address issues pertinent to mood in pregnancy. The course compiles five modules delivered in the form of an online slideshow with audio. It can be accessed from a range of devices. There are a series of worksheets the user can access and download which accompany the modules.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Enjoy Your Bump

Online life skills course based on Cognitive Behavioural Therapy Principles.

Intervention Type DEVICE

Other Intervention Names

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Five Areas Ltd Enjoy Your Bump

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnancy
* Mild-moderate chronic perinatal mental health identified by a score of 2 or higher on PHQ-2 and/or GAD-2.
* 16+0 to 32+6 weeks at recruitment

Exclusion Criteria

* Severe perinatal mental health problem such as schizophrenia, bipolar disorder, substance abuse/dependence, active risk of self-harm.
* Already receiving psychological therapy.
* Insufficient English language to engage with intervention or complete questionnaires.
* Unable to give informed consent.
* Illiterate
* No internet access
* Taking part in another current research project focused on mental health.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Edinburgh & Lothians Health Foundation

UNKNOWN

Sponsor Role collaborator

Tommy's Edinburgh Maternal & Fetal Health Centre

UNKNOWN

Sponsor Role collaborator

National Health Service (NHS) Lothian

UNKNOWN

Sponsor Role collaborator

Five Areas Ltd

UNKNOWN

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca M Reynolds, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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NHS Lothian / University of Edinburgh

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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AC17015

Identifier Type: -

Identifier Source: org_study_id

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