Clinical trial NCT03373734: Enjoy Your Bump : Online Cognitive Behavioural Therapy in Pregnancy
Official title: Feasibility Study Investigating the Efficacy and Acceptability of a Pregnancy Focussed Online Cognitive Behavioural Therapy Package: Enjoy Your Bump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Mental Health
Antenatal Depression
Antenatal Anxiety
Keywords: Online Cognitive Behavioural Therapy
Pregnancy
Self-help
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Edinburgh & Lothians Health Foundation
name: Tommy's Edinburgh Maternal & Fetal Health Centre
name: National Health Service (NHS) Lothian
name: Five Areas Ltd
First posted: 2017-12-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of recruitment and retention.
timeFrame: Measured at 12 months post study start date
measure: Evaluation of feedback questionnaire data.
timeFrame: Measured at 12 months post study start date
measure: Estimation of effect size for changes in depression.
timeFrame: Measured at 12 months post study start date.
measure: Estimate of Effect Size for changes in depression (2)
timeFrame: Measured at 12 months post study start date.
measure: Estimate of effect size for changes in depression (3)
timeFrame: Measured at 12 months post study start date.
measure: Estimation of effect size for changes in anxiety.
timeFrame: Measured at 12 months post study start date.
measure: Estimation of effect size for changes in social function.
timeFrame: Measured at 12 months post study start date.
measure: Estimation of effect size for changes in attachment.
timeFrame: Measured at 12 months post study start date.
Secondary outcomes:
measure: Depression score (1)
timeFrame: 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 score (2)
timeFrame: 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 score (3)
timeFrame: 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 score
timeFrame: 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: Pregnancy Experience
timeFrame: Scores will be recorded at recruitment to study (between 16 - 32+6 weeks gestation), Post Enjoy Your Bump Intervention (before 38 weeks gestation)
measure: Measure mother-baby relationship (Antenatal)
timeFrame: 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: Measure mother-baby relationship (Postnatal)
timeFrame: Score recorded at 12 weeks postnatal
measure: Time taken to complete intervention (1)
timeFrame: 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.
measure: Time taken to complete intervention (2).
timeFrame: 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.
measure: Delivery and support of intervention
timeFrame: 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.
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian / University of Edinburgh
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: Rebecca M Reynolds, PHD
role: PRINCIPAL_INVESTIGATOR
References: