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Enjoy Your Bump - Implementation Study

NCT04700501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-03-14

No results posted yet for this study

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.

Conditions

  • Antenatal Depression

Interventions

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.

Sponsors & Collaborators

  • Tommy's

    collaborator OTHER

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Professor R Reynolds · University of Edinburgh

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2021-06-30
Completion
2022-02-08

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700501 on ClinicalTrials.gov