The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.
Frederik Bernt ScharffMarianne Engelbrecht LauLisa Helena Grønberg RiisagerStine Bjerrum MøllerMehrak Lykkeberg SalimiMatthias GondanSofie FolkePublished in: Pilot and feasibility studies (2020)
The trial is registered at ClinicalTrials.gov (ID: NCT03862703) https://clinicaltrials.gov/ct2/show/NCT03862703 on the 27 of February 2019 and has been approved by the Danish Data Protection Agency (journal number: VD-2018-200 ISuite number 6443). Referring to the committee law §2, the National Committee on Health Research Ethics (DNVK) [H-18024180] decided that the study could proceed without approval as the use of PTSD help did not constitute a health science intervention according to Danish health science legislation.
Keyphrases
- public health
- posttraumatic stress disorder
- randomized controlled trial
- healthcare
- study protocol
- social support
- drug administration
- phase iii
- clinical trial
- phase ii
- mental health
- big data
- health information
- computed tomography
- global health
- health promotion
- electronic health record
- quality improvement
- social media
- open label
- deep learning
- data analysis