The statistical package IBM SPSS Statistics version 22.0 for Windows will be used for data analyses. Baseline differences between groups will be explored for continuous and categorical measures using both t-tests and chi-square tests. Repeated-measures ANOVAs will be used to assess within-group changes over time in primary and secondary outcome measures. Effect sizes will be estimated using Cohen’s d. Linear regression models will be used to study the effect of different variables (e.g., gender, age, and treatment expectations) on adherence and response to the intervention. Any participants who do not complete the post-intervention assessment will be considered drop-outs. On the other hand, the number of times each patient uses the program will be used as the measure of adherence.
Before analyzing the data, a review of state-of-the-art analytic methodology for RCT will be carried out in order to ensure the use of the most suitable statistical analyses. Finally, following SPIRIT and CONSORT guideline recommendations, both intention-to-treat and per-protocol analyses will be reported [34 (link), 36 (link)].
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