Effects of IMR: a randomized controlled trial 111 Differences in results between these studies may be related to variations in patient populations, sample sizes, control group characteristics, the duration of IMR, dropout rates, and model fidelity (6, 29). The present study is focused on two implementation aspects that may have contributed to the inconsistency in the results of earlier RCTs: model fidelity and IMR completion. Fidelity is defined as the degree of adherence to the standards and principles of a program model (30, 31). There are indications that higher fidelity to empirically supported mental health program models, notably evidence-based practices (EBPs), is predictive of better client outcomes for people with SMIs (32). With respect to this predictive validity, there is some evidence regarding several interventions for this target group: Assertive Community Treatment (ACT) (33–37), Individual Placement and Support (IPS) (38), and IMR (39). Before conducting the current study, we conducted a pilot study to explore the feasibility of a randomized controlled trial. This pilot study indicated that an RCT appeared feasible. However, the results likewise indicated a 50% dropout rate from the treatment regimen (30). The relevance of IMR completion (22, 40), including with respect to both fidelity and completion (27), has been suggested in prior research. Therefore, the current study explored the impact of fidelity and IMR completion rate on the efficacy of this intervention. The study design was customized to facilitate completion analysis: a priori, we chose to assign more clients to the experimental condition (IMR) than to the CAU group (6). Although IMR appeared promising for implementation in the Netherlands, the inconsistent findings within previous studies indicated the need for further thorough research on IMR efficacy and outcomes. Therefore, the present study aimed to compare IMR plus care as usual (CAU) with CAU alone in patients with schizophrenia or other SMIs. Using multiple outcome measures of illness selfmanagement, illness outcomes, and recovery, the present study sought to thoroughly assess the effects of IMR. We formulated multiple hypotheses as follows: (1) IMR + CAU allows for better illness management as well as reducing symptoms and relapses as compared with CAU alone; (2) IMR + CAU allows for better personal and functional recovery as compared with CAU alone; and (3) IMR + CAU related improvement is associated with the fidelity of IMR implementation (6). The adaptation of the study design to facilitate completion analysis was based on the proposition that a higher rate of completion is associated with stronger effects.
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