Primary outcome
The primary outcome was available for 117/119 participants (98.3%). In the ITT analysis, 31/71 (44%) of the participants discontinued ADM in the SPD+MBCT group versus 15/46 (33%) in the SPD group: OR 1.60 (95% CI 0.73 to 3.49), corresponding to a number needed to treat of 9. Only 20/73 patients allocated to MBCT (27%) completed the intervention. In the PP analysis, 10/20 (50%) of the participants discontinued ADM in the SPD+MBCT group versus 15/46 (33%) in the SPD group: OR 2.06 (95% CI 0.69 to 6.14), corresponding to a number needed to treat of 6.Of the 31 patients who discontinued in the SPD+MBCT group, 13 (42%) restarted during the 12-month study period, 11 (35%) did not, and for seven (23%) it was unknown. Of the 15 patients who discontinued in the SPD group, nine (60%) restarted, five (33%) did not, and for one (7%) it was unknown.