NCT04700501

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2022

Completed
Last Updated

March 14, 2022

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

November 30, 2020

Last Update Submit

March 11, 2022

Conditions

Antenatal Depression

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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 Outcomes (2)

  • To measure the post-natal Edinburgh Postnatal Depression Scale (EPDS) scores when taken at 6-12 weeks by NHS Health Visitors.

    Through study completion, up to 1 year

  • To measure the number of participants consented into the study.

    Through study completion, up to 1 year

Study Arms (1)

EYB Implementation study

OTHER

All participants will have the opportunity to access an online CBT life skills learning programme.

Other: Enjoy Your Bump - CBT life skills learning programme

Interventions

Enjoy Your Bump - CBT life skills learning programmeOTHER

Antenatal use of an online Cognitive Behavioural Therapy life skills learning programme to improve maternal feelings of anxiety and low mood.

EYB Implementation study

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • week gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh, Queens Medical Research Facility

Edinburgh, EH16 4TJ, United Kingdom

Location

Related Publications (7)

  • Antenatal and postnatal mental health: clinical management and service guidance. National Institute of Health and Clinical Excellence (NICE) guidelines [CG192] Published date: December 2014

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 15094259BACKGROUND

  • 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.

    PMID: 11485953BACKGROUND

  • 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.

    PMID: 26991368BACKGROUND

  • 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.

    PMID: 26928898BACKGROUND

Related Links

Study Officials

  • Professor R Reynolds

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: implementation study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

January 8, 2021

Study Start

January 5, 2021

Primary Completion

June 30, 2021

Study Completion

February 8, 2022

Last Updated

March 14, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)