Analysis
depressed
The Statistical Analysis Plan was finalized on 29 April 2021 prior to analysis, uploaded to the ANZCT site and is available by request. A multilevel mixed-effects model, which took into account participants being nested within clusters, examined whether changes in the continuous outcomes of interest varied over time and across the two groups, after adjustment for potential confounders. The model included fixed effects for the treatment group, time-point, and the treatment-by-time-point interaction. For the one binary outcome of whether participants were depressed on not using the SADQ-21,A per-protocol analysis included only those participants who had completed three or more face-to-face sessions, had both pre-and post-measures collected, and had intervention delivered by a therapist who passed the treatment fidelity check. Adherence to the phone calls was not considered in the per-protocol analysis as there was little compliance. To determine whether significant differences were meaningful, individual participant data analysis was undertaken