Background
National guidelines in the United Kingdom, United States of America, Canada, and Australia have
recently stressed the importance of identifying and treating antenatal anxiety and depression.
However, there is little research into the most effective and acceptable ways of helping women
manage their symptoms of anxiety and stress during pregnancy. Research indicates the necessity to
consider the unique needs and concerns of perinatal populations to ensure treatment engagement,
highlighting the need to develop specialised treatments which could be integrated within routine
antenatal healthcare services. This trial aims to develop a brief intervention for antenatal anxiety,
with a focus on embedding the delivery of the treatment within routine antenatal care.
Methods/Design
This study is a two-phase feasibility trial. In phase one we will develop and pilot a brief intervention
for antenatal anxiety, blended with group support, to be led by midwives. This intervention will draw
on cognitive behavioural principles and wider learning from existing interventions that have been
used to reduce anxiety in expectant mothers. The intervention will then be tested in a pilot
randomised controlled trial in phase two. The following outcomes will be assessed: i) number of
participants meeting eligibility criteria; ii) number of participants consenting to the study; iii) number
of participants randomised; iv) number of sessions completed by those in the intervention arm; and
v) number of participants completing the post-intervention outcome measures. Secondary outcomes
comprise: detailed feedback on acceptability, which will guide further development of the
intervention; and outcome data on symptoms of maternal and paternal anxiety and depression,
maternal quality of life, quality of couple relationship, mother-child bonding, infant temperament
and infant sleep.
2
Discussion
The study will provide important data to inform the design of a future full-scale randomised
controlled trial of a brief intervention for anxiety during pregnancy. This will include information on
its acceptability and feasibility regarding implementation within current antenatal services, which will
inform whether ultimately this provision could be rolled out widely in healthcare settings.