Stefan Elbers

180 Chapter 7 Ethical Approval The study activities have been reviewed and approved by the Medical Research Ethics Committee Utrecht (19/406/D). Protocol modifications that will result in significant changes of study objectives, design, or procedures will require approval by the AGRIPPA steering committee and the Medical Research Ethics Committee. The trial will be coordinated by a senior researcher of the Lifestyle & Health Research Group of the University of Applied Sciences Utrecht. The AGRIPPA consortium that consists of all project partners (including the participating treatment centers) meets twice per year to discuss overall progress and topics such as dissemination. The AGRIPPA steering committee consists of researchers who meet four times per year to oversee the quality of the research and to decide on any substantial amendments to the initial project idea. Study Setting Six treatment facilities that provide IMPT progammes participate in this study (2 hospital units and 4 rehabilitation clinics). All locations provide an interdisciplinary biopsychosocial-oriented treatment progamme to patients within the region, leading to a mixed rural and urban population throughout the Netherlands (i.e. Arnhem, Eindhoven, Hoensbroek, Roermond, Maastricht, and Wijk aan Zee). Eligibility Criteria Patients. All patients who participate in one of the treatment progammes will be eligible to participate in this study. To be admitted to one of the treatment progammes, patients must be over 18 years of age and referred by a general practitioner or medical specialist for IMPT. Furthermore, patients must have received a diagnosis of chronic musculoskeletal pain (i.e. pain localized in the muscles, tendons, bones, and joints) that lasts or recurs for more than 3 months, and significantly interferes with physical, psychological, and social functioning. Patients have to consent to a biopsychosocial form of treatment and to participate actively throughout the treatment progamme. Patients with dominant psychiatric comorbidities (e.g., severe depression) and pending legal procedures that are thought to interfere with rehabilitative success will not be eligible for treatment. In all participating treatment facilities, this standard screening procedure is performed by a physician in rehabilitation medicine. Health Care Providers. To qualify for participation, treatment teams will be required to attend a workshop where they will receive instruction on how to adhere to the study protocol and how to use the app. In addition, health care providers will be instructed to document notable or unexpected events and to participate in a focus group after the study