title: Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  National guidelines in the UK, 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
  This study is a two-phase feasibility trial. In phase 1 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 2. The following outcomes will be assessed: (1) number of participants meeting eligibility criteria, (2) number of participants consenting to the study, (3) number of participants randomised, (4) number of sessions completed by those in the intervention arm, and (5) 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN95282830 . Registered on 29 October 2014.
authors.affiliation: Centre for Mental Health, Imperial College London, 7th Floor Commonwealth Building, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK.|Central and North West London NHS Foundation Trust, Stephenson House, 75 Hampstead Road, London, NW1 2PL, UK.|Institute of Psychiatry, Psychology & Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.
authors.forename: Esther L
authors.initials: EL
authors.lastname: Wilkinson
authors.affiliation: University of Exeter, Mood Disorders Research Centre, Perry Road, Exeter, EX4 4QG, UK.
authors.forename: Heather A
authors.initials: HA
authors.lastname: O'Mahen
authors.affiliation: Research Department of Clinical, Educational and Health Psychology, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.
authors.forename: Pasco
authors.initials: P
authors.lastname: Fearon
authors.affiliation: Department of Psychology, 2 South, University of Bath, Bath, BA2 7AY, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Halligan
authors.affiliation: Centre for Mental Health, Imperial College London, 7th Floor Commonwealth Building, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK.|Central and North West London NHS Foundation Trust, Stephenson House, 75 Hampstead Road, London, NW1 2PL, UK.
authors.forename: Dorothy X
authors.initials: DX
authors.lastname: King
authors.affiliation: School of Public Health, Faculty of Medicine, Imperial College London, Reynolds Building, Charing Cross Campus, St Dunstan's Road, London, W6 8RP, UK.
authors.forename: Geva
authors.initials: G
authors.lastname: Greenfield
authors.affiliation: NHS England, Nursing Directorate, Skipton House, 80 London Road, London, SE1 6LH, UK.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Dunkley-Bent
authors.affiliation: Parent-Infant Research Institute, Department of Clinical & Health Psychology, Centaur Building, Heidelberg Repatriation Hospital, Austin Health, 300 Waterdale Road, Heidelberg Heights, Melbourne, VIC, Australia.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ericksen
authors.affiliation: Parent-Infant Research Institute, Department of Clinical & Health Psychology, Centaur Building, Heidelberg Repatriation Hospital, Austin Health, 300 Waterdale Road, Heidelberg Heights, Melbourne, VIC, Australia.|Psychological Sciences, Level 12, Redmond Barry Building 115, University of Melbourne, Parkville, VIC, 3010, Australia.
authors.forename: Jeannette
authors.initials: J
authors.lastname: Milgrom
authors.affiliation: Centre for Mental Health, Imperial College London, 7th Floor Commonwealth Building, Hammersmith Campus, Du Cane Road, London, W12 0NN, UK. p.ramchandani@imperial.ac.uk.|Central and North West London NHS Foundation Trust, Stephenson House, 75 Hampstead Road, London, NW1 2PL, UK. p.ramchandani@imperial.ac.uk.
authors.forename: Paul G
authors.initials: PG
authors.lastname: Ramchandani
mesh_terms: D001007:Anxiety / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D001833:Body Temperature Regulation; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D004739:England; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008880:Midwifery; D009034:Mother-Child Relations; D010865:Pilot Projects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D011295:Prenatal Care / Q000379:methods*; D011569:Psychiatric Status Rating Scales; D011614:Psychotherapy, Brief; D011615:Psychotherapy, Group; D011788:Quality of Life; D012107:Research Design; D012890:Sleep; D013997:Time Factors; D016896:Treatment Outcome
keywords: Antenatal; Anxiety; Cognitive behavioural therapy; Feasibility; Group intervention