Perinatal Mental HealthNCT03373734
Enjoy Your Bump : Online Cognitive Behavioural Therapy in Pregnancy
A study testing Enjoy Your Bump in people with Perinatal Mental Health and Antenatal Depression, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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'. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Perinatal Mental Health, Antenatal Depression, Antenatal Anxiety
- What is being tested?
- Enjoy Your Bump
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Mild-moderate chronic perinatal mental health identified by a score of 2 or higher on PHQ-2 and/or GAD-2.
- 16+0 to 32+6 weeks at recruitment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Lothian / University of Edinburgh
Edinburgh, Scotland, EH16 4TJ
About this study
Official title: Feasibility Study Investigating the Efficacy and Acceptability of a Pregnancy Focussed Online Cognitive Behavioural Therapy Package: Enjoy Your Bump
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.
Read the detailed description
'Enjoy Your Bump (EYB)' is an online life skills course based on Cognitive Behavioural Therapy (CBT) principles which has been designed to specifically support women in the antenatal period. A survey of women and health professionals has demonstrated that this is a resource that both groups find acceptable. The aim of this quasi-experimental feasibility study is to evaluate the user experience and efficacy of this online programme as a non-pharmacological, low intensity intervention for women experiencing mild-moderate depressive symptoms in pregnancy. This will be achieved by measuring depression and anxiety as well as measures of attachment to the developing baby, pre and post intervention. It is hoped the results from this study will help inform whether this is a resource that should be made more widely available to women in the National Health Service (NHS). It is hypothesised that the 'Enjoy Your Bump' will be an acceptable and effective intervention for women experiencing mild to moderate depressive symptoms in the antenatal period.
- Being tested
- Enjoy Your Bump
- Keywords
- Online Cognitive Behavioural Therapy, Pregnancy, Self-help
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enjoy Your BumpDevice
Also called Five Areas Ltd Enjoy Your Bump
Online life skills course based on Cognitive Behavioural Therapy Principles.
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: 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: 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: Measured at 12 months post study start date.
Secondary outcomes (10)
Depression score (1)
Measure depression pre and post intervention using a standardised assessment tool:
Patient Health Questionnaire-9 (PHQ-9). This standardised questionnaire measures depression. Score ranges 0-27 with 0 representing least depressed and 27 representing most depressed.
Measured: 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)
Measure depression pre and post intervention using standardised assessment tool:
Edinburgh Postnatal Depression Score (EPDS). Another standardised questionnaire. Scores range from 0-30. '0' represents least depressed and '30' represents most depressed.
Measured: 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)
Measure depression pre and post intervention using standardised assessment tool:
. Warwick Edinburgh Mental Wellbeing Scale (WEMWS). Another standardised assessment of mood. Scores range from 14 - 70. '14' represents most depressed and '70' represents least depressed.
Measured: 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
Measure anxiety pre and post intervention using standardised assessment tool Generalised Anxiety Disorder-7 Item scale (GAD-7). This standardised questionnaire gives a score between '0-21'. '0' represents the least anxious and '21' represents the most anxious.
Measured: 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
Measure pregnancy experience pre and post intervention using the Pregnancy Experience Scale (PES). This 41-item questionnaire measures participants feelings towards social issues related to their pregnancy. Total score ranges from 0-123. '0' represents no negative feelings towards experience in pregnancy and '123' represents maximum negative experience towards experience of pregnancy.
Measured: Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation)
Measure mother-baby relationship (Antenatal)
Evaluate the mother-baby attachment in the antenatal period pre and post intervention using the Prenatal Attachment Inventory (PAI)
The Prenatal Attachment Inventory is a 21-item questionnaire with scores ranging from 21-84 with '21' representing most attached and '84' the least attached.
Measured: Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), and Post Enjoy Your Bump Intervention (before 38 weeks gestation)
Measure mother-baby relationship (Postnatal)
Evaluate the mother-baby attachment post intervention in the postnatal period using The Maternal Attachment Inventory (MAI).
The Maternal Attachment Inventory is a 26-item questionnaire. Total ranges from '26-104'. 26 represents poor attachment and 104 represents good attachment.
Measured: Score recorded at 12 weeks postnatal
Time taken to complete intervention (1)
Quantify how long it typically takes participants to complete the intervention.
This will be assessed in 'minutes participant spent active using the intervention'. This data in recorded on the online programme for researcher to see. We will also measure in weeks, how long it took participants to complete all 5 modules of the Enjoy Your Bump intervention.
Measured: Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.
Time taken to complete intervention (2).
Quantify how long it typically takes participants to complete the intervention. We will measure in weeks and days, how long it took participants to complete all 5 modules of the Enjoy Your Bump intervention from recruitment date.
Measured: Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.
Delivery and support of intervention
Test and evaluate the ability to deliver and support the intervention. This will be measured by asking participants in the evaluation questionnaire to comment on how they evaluated the support they received.
Measured: Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start5 May 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Mental HealthStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Edinburgh & Lothians Health Foundation, Tommy's Edinburgh Maternal & Fetal Health Centre, National Health Service (NHS) Lothian, Five Areas Ltd
- Responsible party
- Sponsor
- Investigators
- Rebecca M Reynolds, PHD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373734
- Sponsor's protocol ID
- AC17015
- Status last verified
- Jun 2024
- First submitted
- 11 Oct 2017
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Investigating the Efficacy and Acceptability of a Pregnancy Focussed Online Cognitive Behavioural Therapy Package: Enjoy Your Bump
- ClinicalTrials.gov ID
- NCT03373734
- Acronym / sponsor ID
- AC17015
- Keywords
- Online Cognitive Behavioural Therapy, Pregnancy, Self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Edinburgh & Lothians Health Foundation, Tommy's Edinburgh Maternal & Fetal Health Centre, National Health Service (NHS) Lothian, Five Areas Ltd
- Study start
- 5 May 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
'Enjoy Your Bump (EYB)' is an online life skills course based on Cognitive Behavioural Therapy (CBT) principles which has been designed to specifically support women in the antenatal period. A survey of women and health professionals has demonstrated that this is a resource that both groups find acceptable. The aim of this quasi-experimental feasibility study is to evaluate the user experience and efficacy of this online programme as a non-pharmacological, low intensity intervention for women experiencing mild-moderate depressive symptoms in pregnancy. This will be achieved by measuring depression and anxiety as well as measures of attachment to the developing baby, pre and post intervention. It is hoped the results from this study will help inform whether this is a resource that should be made more widely available to women in the National Health Service (NHS). It is hypothesised that the 'Enjoy Your Bump' will be an acceptable and effective intervention for women experiencing mild to moderate depressive symptoms in the antenatal period.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- 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.
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Mild-moderate chronic perinatal mental health identified by a score of 2 or higher on PHQ-2 and/or GAD-2.
- 16+0 to 32+6 weeks at recruitment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enjoy Your BumpAlso: Five Areas Ltd Enjoy Your BumpOnline life skills course based on Cognitive Behavioural Therapy Principles. | Device | – |
Primary outcome
Evaluation of recruitment and retention.
Time frame: Measured at 12 months post study start date
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.
Evaluation of feedback questionnaire data.
Time frame: Measured at 12 months post study start date
Evaluate the qualitative feedback women give regarding their experience of the intervention using an online questionnaire.
Estimation of effect size for changes in depression.
Time frame: Measured at 12 months post study start date.
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.
Estimate of Effect Size for changes in depression (2)
Time frame: Measured at 12 months post study start date.
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.
Estimate of effect size for changes in depression (3)
Time frame: Measured at 12 months post study start date.
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.
Estimation of effect size for changes in anxiety.
Time frame: Measured at 12 months post study start date.
Effect size for Anxiety will be measured using SMD for Generalised Anxiety-7 questionnaire scores before and after intervention.
Estimation of effect size for changes in social function.
Time frame: Measured at 12 months post study start date.
Effect size for social function will be measured using SMD for score on pregnancy experience scale (PES) pre and post intervention.
Estimation of effect size for changes in attachment.
Time frame: Measured at 12 months post study start date.
Effect size in attachment will be measured using SMD for scores on Prenatal Attachment Inventory both before and after intervention.
10 secondary outcomes
Depression score (1)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation)
Measure mother-baby relationship (Antenatal)
Time frame: Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), and Post Enjoy Your Bump Intervention (before 38 weeks gestation)
Measure mother-baby relationship (Postnatal)
Time frame: Score recorded at 12 weeks postnatal
Time taken to complete intervention (1)
Time frame: Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.
Time taken to complete intervention (2).
Time frame: Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.
Delivery and support of intervention
Time frame: Data will be recorded at participant completion of Enjoy Your Bump intervention. Participants are required to complete intervention before they are 38+0 weeks pregnant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca M Reynolds, PHD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enjoy Your Bump in people with Perinatal Mental Health and Antenatal Depression, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of recruitment and retention. (time frame: Measured at 12 months post study start date). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.