Enjoy Your Bump - Implementation Study

March 11, 2022 updated by: University of Edinburgh

On-line Cognitive Behavioural Therapy Intervention in Pregnancy 'Enjoy Your Bump': an Antenatal Intervention for Perinatal Anxiety

Enjoy Your Bump is an implementation study relating to antenatal maternal mental health in women who have mild to moderate feelings of depression and anxiety. The investigators aim to address the following research question: Is a pregnancy-specific online CBT based life skills course (EYB) delivered antenatally clinically effective in improving maternal anxiety symptom scores immediately post-intervention and at 12 weeks postpartum?

The investigators hypothesise that a pregnancy specific on-line CBT intervention delivered antenatally will improve PNMH during pregnancy and that this will be sustained at 3 months post-partum with beneficial effects for mother and child.

The pregnancy specific online CBT tool Enjoy Your Bump (EYB) course teaches CBT-based life skills to expecting mothers in a fun and low-jargon way. Participants are asked to complete 5 'core' modules and encouraged to take their time to learn, reflect and practice these new life skills.

The investigators anticipate recruiting approximately 100 women to participate in this implementation study. Mental health assessments will be conducted before starting the CBT programme, on completion of the programme and again at 6-12 weeks postnatal. The investigators anticipate an improvement in maternal mental health assessment scores in women who have completed the course and the investigators hope to observe a longer term effect in scores at 6-12 weeks postnatal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One in four women have mental health problems, such as feeling anxious or depressed, during pregnancy and following childbirth. This not only impacts on the woman's own wellbeing but can also adversely affect the physical development and mental wellbeing of her child. The National Health Service (NHS) Long Term Plan aims to be able to provide better access to quality psychological interventions for women with mental health problems in pregnancy. Since the start of the Covid-19 outbreak in March 2020, pregnant women have been placed in a vulnerable group. There have been dramatic changes to maternity services in the community and hospital settings with remote midwife visits and changes to antenatal services. The normal support from friends and family has been reduced due to the current social distancing guidelines. This has all led to an increase in levels of stress and anxiety in the antenatal population.

The investigators have developed a unique pregnancy-specific on-line educational CBT based life skills course called Enjoy Your Bump (EYB). Unlike other CBT tools currently in use, this tool is specifically designed for use by pregnant women with chronic PNMH problems like elevated anxiety, mild depressive symptoms or high levels of self-reported stress. It also addresses specific concerns that women have during pregnancy, is the only pregnancy specific on-line CBT tool available and teaches CBT-based life skills in a fun and low-jargon way.

This implementation study will be open to any pregnant women in NHS Lothian who are experiencing mild or moderate symptoms of anxiety or depression. All pregnant women have access to an antenatal booking appointment with the community midwife following a positive pregnancy test. Women receive routine antenatal appointments during other stages of pregnancy and can participate in the study at any time point up to 32 weeks of pregnancy. During the booking appointment women are routinely asked two mental health questions:

  1. During the past month has the participant often been bothered by feeling down, depressed or hopeless?"
  2. During the past month has the participant often been bothered by having little interest or pleasure in doing things?"

If participants answer yes to either of these questions, the midwife can direct them to the online Enjoy Your Bump study website to gain further information about the study.

Information about this study will also be displayed in maternity waiting rooms in hospitals and on-line websites and women can self refer to participate.

Following completion of three baseline questionnaires, the participants will be provided with a link to the Enjoy Your Bump website. It can be completed using a tablet, smart phone, computer or kindle and is delivered as a modular intervention.

Women are asked to complete 5 'core' modules. There are additional optional modules and support materials the women can access to support their journey through the programme. The modules are supported by completion of 'worksheets' which can be accessed electronically. EYB is unique, as it is tailored to include specific issues relevant to pregnancy. At approximately 36 weeks gestation (after completion of the modules) the participants will be asked to complete 3 short questionnaires either by phone or by an email link to the study website. As part of routine practice all women receive a 6-12 week community follow up appointment by a health care professional. During this appointment the EPDS questionnaire is collected to assess postnatal mental Health.

Study Type

Interventional

Enrollment (Actual)

51

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 Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4TJ
        • University of Edinburgh, Queens Medical Research Facility

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 16 or over,
  • Capacity to give informed consent to participate in the study,
  • Mild to moderate chronic Perinatal mental health (PMH) problems Score ≥3 on PHQ- 2,
  • 8-32 week gestation

Exclusion Criteria:

  • Severe Perinatal mental health problem - schizophrenia, bipolar disorder,
  • Substance abuse/dependence,
  • Active risk of self-harm,
  • Insufficient English language to engage with intervention,
  • No access to the internet

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EYB Implementation study
All participants will have the opportunity to access an online CBT life skills learning programme.
Other: Enjoy Your Bump - CBT life skills learning programme
Antenatal use of an online Cognitive Behavioural Therapy life skills learning programme to improve maternal feelings of anxiety and low mood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure any change from baseline mental health scores when the General Anxiety Disorder-7 (GAD-7) is repeated on completion of the course, or at 36 weeks' gestation.
Time Frame: Through study completion, up to 1 year
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Through study completion, up to 1 year
To measure any change from baseline mental health scores when the Patient Health Questionnaire -8 (PHQ-8) is repeated on completion of the course, or at 36 weeks' gestation.
Time Frame: Through study completion, up to 1 year
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. Eight patient questions, each of which is scored 0 to 3, providing a 0 to 24 severity score. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of - not at all, several days, more than half the days, and nearly every day, respectively. PHQ-8 total score for the eight items ranges from 0 to 24. Scores of 5, 10, 15, and 20 represent cut off points for mild, moderate, moderately severe and severe depression, respectively.
Through study completion, up to 1 year
To measure any change from baseline mental health scores when the Edinburgh Postnatal Depression Score is repeated on completion of the course, or at 36 weeks' gestation.
Time Frame: Through study completion, up to 1 year
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving short term maternal mental health scores following the CBT intervention. The scale consists of 10 short statements. A mother checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30).
Through study completion, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the post-natal Edinburgh Postnatal Depression Scale (EPDS) scores when taken at 6-12 weeks by NHS Health Visitors.
Time Frame: Through study completion, up to 1 year
To determine if a pregnancy-specific online Cognitive Behavioural Therapy (CBT) based life skills course delivered antenatally is effective in improving maternal mental health scores at 6- 12 weeks following birth. The scale consists of 10 short statements. A mother checks off one of four possible answers that is closest to how she has felt during the past week. Responses are scored 0, 1, 2 and 3 based on the seriousness of the symptom. The total score is found by adding together the scores for each of the 10 items. None or minimal depression (0-6), Mild depression (7-13), Moderate depression (14-19), Severe depression (19-30). A higher score is indicative of poorer mental health.
Through study completion, up to 1 year
To measure the number of participants consented into the study.
Time Frame: Through study completion, up to 1 year
To assess the uptake and completion of the CBT course.
Through study completion, up to 1 year

Collaborators and Investigators

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

Sponsor

University of Edinburgh

Collaborators

Tommy's

Investigators

  • Principal Investigator: Professor R Reynolds, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 5, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

February 8, 2022

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC20128
  • 285587 (Other Identifier: IRAS)
  • 20/SS/0100 (Other Identifier: Reviewing Ethics Committee (REC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Antenatal Depression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe