Study protocol 79 Limitations Firstly, no structured diagnostic interview will be used to confirm the DSM-IV diagnosis. Practical considerations underlay our choice of the clinical diagnosis reported by clinicians on the basis of the medical records; due to the limited relevance of a DSM-IV diagnosis to the present study, this seems to be sufficient. Another limitation is the chance of recruitment bias. As we consider clinicians to be responsible for treatment, it will be they who suggest that particular clients participate in IMR, and who inform these clients about the study. Although an interview with an assistant researcher will be used to screen all clinicians’ total caseloads for their potential suitability for IMR, and although the clinicians are indeed supposed to ask all selected clients to participate in IMR and to inform them about the study, some clinicians may prefer certain clients for participation in IMR— those whose functioning is better, for example. Some of these selected clients are therefore likely to participate in this study. We will explore which criteria the clinicians use to select participants for IMR. A further limitation is that the clinicians who score two questionnaires will not be blind for the condition. On the other hand, they will not be involved in the IMR training. Neither, due to the use of self-score questionnaires, will they be blind for the clients. The use of multiple scales to assess aspects of objective and subjective recovery is a limitation, as multiple testing may introduce positive findings. However, given the comprehensive nature of the IMR model and training programme, we felt that it would not be enough to use IMR scales alone (23, 24), and that a more comprehensive set of scales was needed. By limiting the cost-utility analyses to health care consumption alone, we will not be able to include potential reductions in social costs, such as those that might occur if IMR participants manage their symptoms well enough to be able to work. But a full assessment of costs is beyond the scope of this study. Finally, IMR will be offered in our study in a group format, and will be compared with care as usual, which will largely involve an individual format. Some of the possible effect in a group format may be attributable to peer-group support. If evidence provides support for IMR, IMR may be recommended as part of the guidelines for SMI care and be implemented more broadly. This will enable it to meet a need for a structured psychosocial intervention that supports illness management and recovery.
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