Protocol deviations and adverse events
ADVERSE EVENTS, EVENTS
Three protocol deviations were reported during the controlled study period of 7 weeks, all in the waiting list group condition. Two participants reported changes in their prescribed type of antidepressant and one reported discontinuation of taking antidepressants. The efficacy analyses were run again while excluding these participants and the results remained the same (data not shown) as in the primary analysis.In the CIPE group, 16 participants (31%) reported a total of 63 adverse events (Frequency and types of adverse events during the controlled study periodNote that in the 27 participants that reported adverse events, the average number of reported events were 4 in the CIPE group and 3 in the waiting list group. CIPE, Condensed Internet-delivered Prolonged Exposure; WL, waiting list.