Curth, Nadja Kehler http://orcid.org/0000-0002-1485-300X
Brinck-Claussen, Ursula
Jørgensen, Kirstine Bro
Rosendal, Susanne
Hjorthøj, Carsten
Nordentoft, Merete
Eplov, Lene Falgaard
Funding for this research was provided by:
Ministry of Health and Prevention
Article History
Received: 21 September 2018
Accepted: 13 August 2019
First Online: 25 October 2019
Ethics approval and consent to participate
: The trials are conducted in compliance with the protocol and the Helsinki Declaration, and follow the rules for informed consent. Any protocol modifications will be described in the reporting of findings. Access to the full protocol can be achieved upon request. All data will be electronically stored and entry restricted. Researchers and project staff members will have access to data. Personally identifiable data will be handled according to the Danish law regarding personal information (‘Lov om behandling af personoplysninger’).The GP obtains patients’ consent to participation. This is based on oral and written information. A friend or family member can be present at an information meeting. Participants have at least 24 h to decide whether they wish to participate. Written consent forms must be signed, and participants receive the original; an electronic copy will be stored in the electronic system REDCap. Participants are informed of their rights to leave the study at any time and with no consequences for future treatment. There are no known circumstances that can lead to exclusion after a patient is included. The participant will be notified if such circumstances arise. The authors are not aware of previous reporting of adverse events of collaborative care. The treatment modalities embedded in the collaborative care model are provided according to National guidelines, and symptom severity and suicidality are monitored.The study protocol has been evaluated and approved by the Regional Ethics Committees of the Capital Region (identification number: H-16034303) and the Danish Data Protection Agency (local journal number: RHP-2017-050, 05910), and has been registered with ClinicalTrials.gov (ExternalRef removed, identification numbers NCT03113175 and NCT03113201). A checklist of Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) is available in Additional file InternalRef removedand a full SPIRIT figure is shown in Fig. InternalRef removed.Findings from the trials will be communicated as part of a Health Technology Assessment and through one or more scientific papers.
: Not applicable.
: The authors declare that they have no competing interests.