Poulsen, Chalotte Heinsvig http://orcid.org/0000-0001-6420-1918
Egmose, Cecilie Høgh
Ebersbach, Bea Kolbe
Hjorthøj, Carsten
Eplov, Lene Falgaard
Funding for this research was provided by:
Velux Fonden (26723)
Article History
Received: 26 April 2021
Accepted: 16 July 2022
First Online: 2 September 2022
Declarations
:
: The trial has been ethically approved by the regional ethics committees of the Capital Region of Copenhagen (number H-20027612). The protocol is registered with ExternalRef removed (NCT04639167), and any study protocol amendments in inclusion criteria or intervention will be submitted to the regional ethics committees of the Capital Region of Copenhagen and registered at ExternalRef removed. The Danish Data Protection Agency has approved the project (P-2020-1010), and the study will be conducted in accordance with applicable regulations. Every participant in the trial has been informed about the objective of the study, as well as the implications of participation, by a local coordinator or researcher of the project and has given oral and written consent to participate before enrolment. Participants will be informed about their right to withdraw from the study at any point and without consequences for their future municipal social service and/or mental health service. If withdrawing, participants can decide if their information, and how much of their information, can be used in the study. Interventions like the PEER intervention have not previously been shown to have adverse effects. Nonetheless, after the intervention phase has ended, we will evaluate negative effects such as hospitalizations, suicide, probable self-harm, and death obtained from the Danish central registers.
: Not applicable
: The authors declare that they have no competing interests.