Study protocol 69 Hypotheses We have two primary hypotheses and four secondary hypotheses. The first primary hypothesis is that IMR + CAU (IMR offered in group format) leads to better illness management and to fewer symptoms and relapses than CAU only. The second primary hypothesis is that IMR + CAU leads to better ‘subjective’ and ‘objective’ recovery than CAU only. We thus expect a condition x time interaction effect of the IMR + CAU group over the CAU-only group. The first secondary hypothesis is that the cost-utility of IMR + CAU is better than that of CAU. We intend to explore the working mechanisms of IMR by testing the second secondary hypothesis that better illness management (i.e. getting greater psychiatric insight, better coping, more social support, less addiction, and better service engagement) leads to fewer symptoms and relapses. We also intend to test the third secondary hypothesis that better ‘distal outcomes’ (i.e. recovery, see Fig.1) result from a combination of better ‘proximal outcomes’ (i.e. better illness management and fewer symptoms and relapses) and progress on personal goals (2). Finally, we expect that any improvement resulting from IMR + CAU will be associated with the fidelity of IMR implementation (fourth secondary hypothesis). Design This research project entails a randomised controlled trial in which clients who provide written informed consent will be assigned to the experimental condition (IMR) or the control group. The experimental group will consist of clients who participate in the IMR programme (which will be offered in a group format) and also get CAU. The control group will receive CAU. Measurement is planned to take place before randomization and at 12 and 18 months after randomization. Participants The participants in the study will be adult SMI outpatient clients aged between 18 and 65 who have given written informed consent. There will be three exclusion criteria: having already participated in IMR training, being unable to give informed consent due to mental incompetence, and insufficient knowledge of the Dutch language.
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