RAPID-2 study: a feasibility randomised controlled trial of a midwife-facilitated intervention for pregnant women with symptoms of mild to moderate anxiety

Abstract Background Anxiety symptoms during pregnancy can escalate and adversely affect women and babies. Support is needed to prevent escalation and help women develop coping strategies. This study aimed to investigate the feasibility of a definitive trial examining the effectiveness of the RAPID-2 intervention for pregnant women with symptoms of mild to moderate anxiety. Methods A two-arm, parallel, open, pragmatic feasibility randomised controlled trial compared usual maternity care plus the RAPID-2 intervention with usual care alone. The study was conducted in 2023 across two NHS maternity services in England. Participants were nulliparous women at 16–20 weeks of pregnancy with symptoms of mild to moderate anxiety, assessed using the seven-item Generalised Anxiety Disorder scale (scores 3–14). RAPID-2 was a 12-week group-based intervention comprising four midwife and maternity support worker-facilitated sessions, two peer-led sessions and access to self-help resources. Four midwives and four maternity support workers were recruited and trained to facilitate the intervention. Objectives were to assess recruitment, retention and completion rates; women’s and facilitators’ experiences; and estimation of anxiety score parameters to inform a future sample size calculation. Results The recruitment target of 50 participants was achieved within 5 weeks, compared with the planned 16-week recruitment period, although study reach was lower than anticipated. Of 101 women provided with study information, 90 (89%) completed eligibility screening and 60 (67% of those screened) were recruited and randomised (31 intervention, 29 control). Post-intervention questionnaires were provided by 18 (30%) participants. Of the 31 intervention participants, six (19%) withdrew before intervention commencement and 15 (48%) attended at least one group. Of those who attended, 11 (73%) attended four or more sessions. Women who attended valued peer support and professional reassurance. Conclusions Women were recruited over a shorter timespan than planned, although recruitment reach, intervention attendance and questionnaire completion were lower than anticipated. Limited outcome data prevented reliable estimation of anxiety score parameters to inform a future trial. The current study design is not feasible for progression to a definitive trial without refinement. Strategies to strengthen inclusive recruitment, intervention accessibility and outcome data collection were identified. Trial registration ISRCTN12834758. Registered 18 March 2022.