Chapter 2 44 Ethical Aspects The study protocol, information brochure and informed consent form for the RCT were approved by the Dutch Union of Medical-Ethical Trial Committees for mental health organizations (registration number of the Dutch National Trial Register NTR 5033 http://www.trialregister.nl, CCMO-no NL38605.078.12). The pilot study was a naturalistic study in which the researchers observed and recorded the implementation of IMR in the institute in its natural setting over a prolonged period, while interfering as little as possible with the subjects and the implementation process. Conducted by researchers employed at Bavo Europoort’s internal research and development department, it was implemented as a routine program evaluation under the regular quality control for care-innovation projects with a local scope. As its objective was not to gain generalizable medical scientific knowledge, it could not be defined as medical research according to the rules of the Dutch Central Committee on Research Involving Human Subjects (CCMO) (60) under the Dutch Medical Research Involving Human Subjects Act (WMO) (61). For this reason, no external medical ethical permission was requested. The study was approved by the medical director of the institute. Potential participants were provided with information on the program evaluation; participation in the evaluation was not a mandatory requirement for participation in the IMR program. Participants were asked individually whether they consented to be interviewed and were asked their permission for the observation of one IMRsession per team for purposes of fidelity measurement. The outcomes were reported anonymously. Results Participant Flow Influx and outflux of participants in IMR In the recruitment phase, 167 clients were asked by their clinicians to participate in IMR. Eighty-one who signed up to participate in IMR (49%) were included in the study and had a first measurement; 73 of the 81 started with the first module (eight dropouts), which was done individually with one clinician. Fifty-one of these 73 participants started with the second module (22 dropouts), which, like the remaining modules, was given in group format. Forty of the 51 attended at least 70% of all sessions (11 dropouts) and were thus considered to be completers (see figure 1). Dropout from the time of commitment to participate in IMR was thus 51%; counted from the start of real participation, it was 45%. Measured from the point
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