A naturalistic pilot study 39 Objectives Objectives and hypotheses of the main study The aim of the RCT is to compare the effectiveness of the IMR training program with that of care as usual (CAU) for patients with SMI. Our hypotheses are inspired by Mueser’s conceptual framework (1, 10). The first primary hypothesis of the main study is that IMR+CAU (where IMR is offered in group format) leads to better illness management and to fewer symptoms and relapses than CAU only. The second primary hypothesis is that, compared to CAU only, IMR+CAU leads not only to better “subjective” recovery (perceived recovery, sense of purpose, and personal agency), but also to better “objective” recovery (role and social functioning). We also have four secondary hypotheses. 1.) We expect the cost-utility of IMR+CAU to be better than that of CAU. 2.) We expect better illness management (i.e., getting more insight, better coping, more social support, less addiction and better service engagement) to lead to fewer symptoms and relapses. Testing this will help us explore the working mechanisms of IMR. (3) The third hypothesis we will test is that, in terms of Mueser (1), better “distal outcomes” (i.e., recovery) result from a combination of better “proximal outcomes” (i.e., better illness management and fewer symptoms and relapses) and progress on personal goals. (4) Finally, we expect that any improvement resulting from IMR+CAU will be associated with the fidelity with which IMR is implemented. Objectives of the pilot study Our primary objectives concern the assessment of the feasibility of implementing the IMR training program on a broader scale at Bavo Europoort. As a satisfactory power level would be achieved only if we included enough patients in the planned RCT—we planned 200—we examined whether the institute would succeed in recruiting sufficient participants for the six IMR groups planned. The institution’s willingness to implement IMR in the long term would depend largely on clients’ and clinicians’ satisfaction with IMR, on which the effectiveness of the program would clearly have a bearing. Our secondary objectives regard the assessment of the quality with which IMR is implemented. Because fidelity is considered to be associated with better outcomes (20), secondary objectives were to evaluate whether it was feasible to apply the 11 modules of IMR with satisfactory fidelity in the Dutch context and to set up an adequate infrastructure for trainers’ training and supervision, which is a precondition for implementing IMR with good fidelity. Further secondary objectives for the pilot study were to explore the duration of the program and dropout from
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