Strenghts and limitations of the pilot RCT
This document describes a summary of the results of a pilot randomised controlled trial (RCT)
conducted in Denmark and Spain and its strengths and limitations (deliverable D5.3. describes in
more detail the results of the pilot RCT). It also contains propositions for future study designs
based on a review of the relevant literature as the pilot RCT demonstrated that a future full-scale
randomised study was unfeasible. In our pilot study, a subset of women from the STOP cohort
study who screened positive for IPV during their first antenatal visit were invited to participate in
pilot randomised controlled trial of psychological counselling by video conference. The objective
was to randomise a total number of 20 participants to either the intervention or the control
group. The intervention group received the e-health package (six video counselling sessions
combined with the use of a safety planning app), while the control group would receive the same
intervention yet with a delay of 8 weeks permitting collection of control outcome data. This
document will interpret the pilot findings and the existing literature to come up with possible
solutions to address the difficulties in the feasibility of a future full-scale randomised study
observed in the pilot study.