Figure 1

Study methodology. 60 participants identified as HFUs who provided informed consent, were randomized using standardized tables. 34 participants were randomised to the intervention group and 26 to the treatment as usual group. Participants from both groups were assessed at inclusion and rating scales as described in the methods section were performed at each of these visits. Participants from both groups were assessed again after 12 months for the final assessment. On this visit data was collected and rating scales were performed again. In each group, 5 participants did not complete the study.