Chapter 3 78 Medical-Ethic Trial Committees for mental health organisations (registration number of the Dutch National Trial Register NTR 5033 http://www.trialregister.nl, CCMO-no. NL 38605.078.12). Discussion As the four RCTs conducted on IMR have yielded mixed results, more research is needed. We therefore aim to compare the effectiveness of the IMR programme with that of CAU in people with SMI. Our first primary hypothesis is that IMR + CAU will lead to better illness management and fewer symptoms and relapses than CAU only. The second primary hypothesis is that IMR + CAU will lead to better ‘subjective’ and ‘objective’ recovery than CAU only. The first secondary hypothesis is that the cost-utility of IMR + CAU will be better than that of CAU. We intend to explore the working mechanisms of IMR by testing a second secondary hypothesis that better illness management will lead to fewer symptoms and relapses. We also intend to test a third secondary hypothesis that better ‘distal outcomes’ (i.e. recovery) will result from a combination of better ‘proximal outcomes’ (i.e. better illness management and fewer symptoms and relapses) and progress on personal goals. Finally, in our fourth secondary hypothesis, we expect that any improvement resulting from IMR + CAU will be associated with the fidelity with which IMR is implemented. Our study has various strengths and limitations. Strengths The first strength is that our use of different outcome measures for each domain will provide a thorough measurement of the effects of IMR on illness management and on subjective and objective recovery. And as well as exploring the contribution made by various illness management variables to illness outcomes, we will also explore the contribution that progress on personal goals makes to subjective and objective recovery. In this way we will be able to analyse the working mechanisms of Mueser’s conceptual framework (2). Other strengths of our study are that it will be conducted in another country than the earlier RCTs. By including 200 participants with various types of SMI, it will also have a relatively large sample size. The numbers of participants in the other completed RCTs were 210 (17), 104 (18), 41 (16) and 118 (15). As the study will be conducted in the everyday clinical practice of the two participating mental health institutions, the generalisability of its results will be good. The measurement procedure at the second and third time of measurement will be single blinded.
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