The RAPID 2 study. Reducing Anxiety in Pregnancy

• Research type

  Research Study

• Full title

  The RAPID 2 study. Reducing Anxiety in Pregnancy: Intervention Development phase 2. A feasibility study of a midwife facilitated supportive intervention.

• IRAS ID

  294369

• Contact name

  Kerry Evans

• Contact email

  kerry.evans@nuh.nhs.uk

• Sponsor organisation

  Managing Director of Research and Innovation

• ISRCTN Number

  ISRCTN12834758

• Duration of Study in the UK

  0 years, 8 months, 27 days

• Research summary

  Each year in the UK approximately 750,000 women use midwifery services, and 14% will experience symptoms of anxiety. Anxiety disorders are associated with postnatal depression, low birthweight, premature birth and developmental and behavioural problems in children. For women with mild-moderate anxiety, psychological support may help reduce anxiety and prevent an escalation of symptoms.
  A preliminary study(RAPID-1)was completed in 2017. The intervention design followed the MRC framework and was informed by psychological theory, systematic review evidence and expert and public involvement. RAPID-1 was the first midwife-led intervention to be evaluated for pregnant women with symptoms of mild to moderate anxiety. The preliminary study demonstrated the intervention could be integrated within routine maternity care and women considered that they benefitted from participating.
  The aim of the RAPID-2 study is to test the feasibility of conducting a trial to examine the effectiveness of a midwife facilitated intervention for pregnant women with symptoms of mild to moderate anxiety. The study objectives are to:
  • To determine the number of women who are eligible and agree to participate in the study.
  • To determine retention rates for the intervention and control arm of the study
  • To assess the recruitment procedures
  • To conduct a qualitative assessment of women’s and facilitators’ experiences
  • To investigate participant-related and service-level factors potentially affecting outcomes
  • To assess the relevance and acceptability of data collection and outcome measures
  Secondary objectives
  • To estimate the parameters of the seven-item Generalised Anxiety Disorder scale (GAD-7) to inform the sample size for a definitive cluster trial.
  • To identify data collection tools for economic evaluation

  A cluster randomised controlled trial will be conducted in four NHS trusts. The aim is to recruit 40-50 nulliparous pregnant women (i.e. women having no previous births) with self-reported symptoms of mild-moderate anxiety. The intervention comprises: 1. One-to-one pre-group midwife meeting; 2. Six group discussion sessions; 3. Self-help materials. The intervention will be delivered over a twelve-week period. Control group participants will receive usual maternity care.

  Summary of Results
  The study recruited women over a shorter timespan than planned although the reach and retention in the study were lower than anticipated. A total of 101 women were approached over a five-week period expressed interested in participating and completed eligibility screening. Of these, 60 women were eligible and participated. Outcome questionnaires were completed by 18 participants. The intervention is not feasible in the current form to continue to a definitive trial, but approaches to strengthen recruitment processes and enhance study retention have been identified.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  22/EM/0018

• Date of REC Opinion

  14 Mar 2022

• REC opinion

  Further Information Favourable Opinion