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Article History

Received: 4 February 2020

Accepted: 27 July 2020

First Online: 17 August 2020

Ethics approval and consent to participate

: The protocol was approved by the Danish Scientific Ethics Committee (1-10-72-204-18), the Innovation Fund Denmark (7038-00157B), and the Data Protection Agency internally at Aarhus University (2016-051-000001, 1159) before patient enrolment. The trial is registered at the ClinicalTrials.gov database (NCT03730974). The Protac Ball Blanket™ is CE registered.In case of protocol amendments, all relevant parties will be notified.We identify no risk, pain or discomfort involved in participating in the trial. Full informed consent will be obtained from all study participants before participation in this trial. The model consent forms are available from the corresponding author on request. This trial does not involve collecting biological specimens, why additional consent provisions are not needed. Participation is completely voluntary, and patients can withdraw from the project at any time. Participation or dropout will have no influence on the usual treatment offered in the psychiatric outpatient clinics. Patients will not receive any payment for participating in the trial. Patient confidentiality will be protected before, during, and after the trial. Data will be entered and securely stored in REDCap. Data will be accessed through secure VPN connections at Aarhus University when analysed by STK. Data will be fully anonymized before being shared with an internal statistician at Aarhus University. The datasets analysed during the current study will be available from the corresponding author on reasonable request. After trial completion, data will be stored at the Danish Data Archive.A co-operation agreement has been produced and signed in collaboration with the legal department at Aarhus University and Protac A/S, Skanderborg, ensuring (1) that Aarhus University owns the final dataset, (2) the company will have no access to the dataset, and (3) all results will be published regardless of whether the results turn out positive or negative.

: Not applicable.

: This is an industry-supported trial. The company Protac A/S covers 50% of STK’s salary in collaboration with The Innovation Fund Denmark, who covers the remaining 50%. However, trial sponsors and funders have no role in the study design; the collection, management, analysis, and interpretation of data; the writing of the report; and the decision to submit the report for publication.