- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03373734
Enjoy Your Bump : Online Cognitive Behavioural Therapy in Pregnancy
Feasibility Study Investigating the Efficacy and Acceptability of a Pregnancy Focussed Online Cognitive Behavioural Therapy Package: Enjoy Your Bump
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rebecca M Reynolds, PHD
- Phone Number: 01312426762
- Email: R.Reynolds@ed.ac.uk
Study Contact Backup
- Name: Fiona C Denison, Reader
- Phone Number: 01312426449
- Email: Fiona.Denison@ed.ac.uk
Study Locations
-
-
Scotland
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Edinburgh, Scotland, United Kingdom, EH16 4TJ
- Recruiting
- NHS Lothian / University of Edinburgh
-
Contact:
- Rebecca M Reynolds, PHD
- Phone Number: 01312426762
- Email: R.Reynolds@ed.ac.uk
-
Contact:
- Fiona C Denison, Reader
- Phone Number: 01312426449
- Email: Fiona.Denison@ed.ac.uk
-
Sub-Investigator:
- Clare M Wallace, MSc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured at 12 months post study start date
|
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.
|
Measured at 12 months post study start date
|
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. |
Measured at 12 months post study start date.
|
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. |
Measured at 12 months post study start date.
|
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. |
Measured at 12 months post study start date.
|
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.
|
Measured at 12 months post study start date.
|
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.
|
Measured at 12 months post study start date.
|
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.
|
Measured at 12 months post study start date.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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. |
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.
|
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. |
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.
|
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. |
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.
|
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.
|
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 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.
|
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)
|
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. |
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
|
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. |
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.
|
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. |
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.
|
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.
|
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.
|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca M Reynolds, PHD, University of Edinburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC17015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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