Effects of IMR: a randomized controlled trial 117 moderate/low fidelity, and control), and their interactions. In cases where there was an overall statistically significant interaction effect, we interpreted the parameter estimates for these interaction effects as appropriate. The cutoff scores for high, moderate, and low fidelity within the IMR fidelity scale were ≥4.0, 3.0–4.0, and <3.0, respectively (54). Statistical analyses were performed using the Statistical Package for the Social Sciences (version 25.0; SPPS, Inc., Chicago, IL, USA). Multiplicity adjustments, including Bonferroni and Benjamini–Hochberg corrections (62), are often applied. However, these methodologies have substantial limitations (63, 64). This study applied 11 secondary outcomes, selected carefully a priori, to explore the effects of various components of the conceptual framework for the IMR program (3). Our analyses followed a pre-specified protocol (6) and we present a qualitative interpretation of our findings. Additionally, as a sensitivity analysis, we present the impact of Benjamini–Hochberg corrections on our results. Due to an administrative oversight, the prospective trial registration was initially overlooked; however, this omission was noticed halfway through the data collection period and the trial was registered with the Netherlands Trial Register (NL4931, NTR5033). Details of our initial ethical approval and protocol are provided in the Supplementary Material. Results Between October 2012 and May 2014, we randomly assigned 187 participants (3:2 ratio) to receive IMR + CAU (n = 116) or CAU alone (n = 71; Figure 2 shows the CONSORT flow chart for study enrollment). There were no between-group differences in baseline demographic or medical characteristics (Table 1), and only 9.4% missing data. On average, participants in the experimental group (n = 116) attended 23.57 IMR sessions (standard deviation (SD) = 21.09), representing 44.6% of all scheduled sessions (SD = 37.3%). IMR completers (n = 57, 49%) attended an average of 42.4 sessions (SD = 12.64), representing 80.1% of the total number of scheduled sessions (SD = 13.05%).
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