ACORN-II: A multi-site randomised COntrolled trial to evaluate the impact of a group tReatment for aNtenatal anxiety
Antenatal anxiety
Potential participants will be screened for anxiety at first-trimester scanning clinics. If individuals score 8 and above on the GAD-7, they will be eligible for the trial. Eligible participants who consent will be randomly allocated on a 1:1 basis to CALM + TAU or TAU only using permuted block randomisation which will be stratified by site and anxiety diagnosis prepregnancy versus de novo antenatal anxiety. Randomisation will be delivered by a web-based randomisation system (integrated within the trial REDCap system). The CALM intervention comprises four 2-hour online group sessions delivered to both the pregnant woman/birthing person and their partner and one 2-hour postnatal reunion. It is delivered by a healthcare and psychological practitioner. The intervention focuses on strategies that: (1) reduce avoidance associated with worry, (2) improve the ability to tolerate uncertainty that contributes to anxious worry in the perinatal period and (3) improve relationship satisfaction through joint communication skills about how to manage worry together.
Pregnant women and birthing persons aged 18+ years who score above clinical threshold (8 or more) (on a standard anxiety screening measure (GAD-7)
1. Actively suicidal 2. Substance abuse 3. Psychosis 4. Have childbirth-related PTSD (i.e., individuals eligible to receive PTSD treatment in maternal mental health services) 5. Receiving current psychological treatment for anxiety at baseline interview