Enjoy Your Bump : Online Cognitive Behavioural Therapy in Pregnancy

NCT03373734 | Completed

• 1 other identifier: AC17015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perinatal Mental Health; Antenatal Depression; Antenatal Anxiety

Keywords

Online Cognitive Behavioural Therapy; Pregnancy; Self-help

Outcome Measures

Primary Outcomes (8)

• Evaluation of recruitment and retention.

  Evaluate how many women are recruited to the study, how many women complete the online modules and how many women give feedback on their experience via an online questionnaire.

  Measured at 12 months post study start date

• Evaluation of feedback questionnaire data.

  Evaluate the qualitative feedback women give regarding their experience of the intervention using an online questionnaire.

  Measured at 12 months post study start date

• Estimation of effect size for changes in depression.

  Obtain an estimate of effect size for changes in depression, from pre to post intervention. Change in effect size for depression will be measured using Standardised Mean Difference (SMD) of scores on Patient Health Questionnaire-9 (PHQ-9) from pre to post intervention.

  Measured at 12 months post study start date.

• Estimate of Effect Size for changes in depression (2)

  Obtain an estimate of effect size for changes in depression, from pre to post intervention. Change in effect size for depression will be measured using Standardised Mean Difference (SMD) of scores on the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) from pre to post intervention.

  Measured at 12 months post study start date.

• Estimate of effect size for changes in depression (3)

  Obtain an estimate of effect size for changes in depression, from pre to post intervention. Change in effect size for depression will be measured using Standardised Mean Difference (SMD) of scores on the Edinburgh Postnatal Depression Score (EPDS) from pre to post intervention.

  Measured at 12 months post study start date.

• Estimation of effect size for changes in anxiety.

  Effect size for Anxiety will be measured using SMD for Generalised Anxiety-7 questionnaire scores before and after intervention.

  Measured at 12 months post study start date.

• Estimation of effect size for changes in social function.

  Effect size for social function will be measured using SMD for score on pregnancy experience scale (PES) pre and post intervention.

  Measured at 12 months post study start date.

• Estimation of effect size for changes in attachment.

  Effect size in attachment will be measured using SMD for scores on Prenatal Attachment Inventory both before and after intervention.

  Measured at 12 months post study start date.

Secondary Outcomes (10)

• Depression score (1)

  Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.

• Depression score (2)

  Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.

• Depression score (3)

  Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.

• Anxiety score

  Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation) and 12 weeks Postnatal.

• Pregnancy Experience

  Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation)

Interventions

Enjoy Your Bump DEVICE

Online life skills course based on Cognitive Behavioural Therapy Principles.

Also known as: Five Areas Ltd Enjoy Your Bump

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• Edinburgh & Lothians Health Foundation: collaborator
• Tommy's Edinburgh Maternal & Fetal Health Centre: collaborator
• National Health Service (NHS) Lothian: collaborator
• Five Areas Ltd: collaborator

Study Sites (1)

NHS Lothian / University of Edinburgh

Edinburgh, Scotland, EH16 4TJ, United Kingdom

Location

Study Officials

• Rebecca M Reynolds, PHD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: December 14, 2017
• Study Start: May 5, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)