Study Results
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Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2021-01-05
2022-02-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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EYB Implementation study
All participants will have the opportunity to access an online CBT life skills learning programme.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Substance abuse/dependence,
* Active risk of self-harm,
* Insufficient English language to engage with intervention,
* No access to the internet
16 Years
FEMALE
Yes
Sponsors
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Tommy's
OTHER
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Professor R Reynolds
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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University of Edinburgh, Queens Medical Research Facility
Edinburgh, , United Kingdom
Countries
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References
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Antenatal and postnatal mental health: clinical management and service guidance. National Institute of Health and Clinical Excellence (NICE) guidelines [CG192] Published date: December 2014
Saving Lives, Improving Mothers' Care. Lessons learned to inform future maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2009-2012
Bauer A, Parsonage M, Knapp M, Lemmi V, Adelaja B. The costs of perinatal mental health problems. London School of Economics and Political Science. 2014.
Heron J, O'Connor TG, Evans J, Golding J, Glover V; ALSPAC Study Team. The course of anxiety and depression through pregnancy and the postpartum in a community sample. J Affect Disord. 2004 May;80(1):65-73. doi: 10.1016/j.jad.2003.08.004.
Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257.
Ashford MT, Olander EK, Ayers S. Computer- or web-based interventions for perinatal mental health: A systematic review. J Affect Disord. 2016 Jun;197:134-46. doi: 10.1016/j.jad.2016.02.057. Epub 2016 Mar 9.
Lee EW, Denison FC, Hor K, Reynolds RM. Web-based interventions for prevention and treatment of perinatal mood disorders: a systematic review. BMC Pregnancy Childbirth. 2016 Feb 29;16:38. doi: 10.1186/s12884-016-0831-1.
Related Links
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Chief Medical Office Annual Report 2014: women's health
Perinatal mental health services needs assessment and recommendations.
Maternal mental health alliance
Five year forward view for mental health. one year on
Other Identifiers
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285587
Identifier Type: OTHER
Identifier Source: secondary_id
20/SS/0100
Identifier Type: OTHER
Identifier Source: secondary_id
AC20128
Identifier Type: -
Identifier Source: org_study_id
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