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The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

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Background: Due to an increase in PTSD patients seeking help in the Danish mental health sector and the
addition of Complex PTSD to the ICD-11, there is a need to increase efficiency of existing treatments for PTSD.
mHealth interventions have been shown to reduce PTSD symptoms. Therefore, the implementation of a mHealth
intervention designed for psychiatric PTSD patients as a therapy add-on may improve treatment outcome. No study
to date has explored the effects of mHealth interventions for PTSD in the Danish mental health sector, the
feasibility and effect of this type of intervention needs testing.
Methods: The study is an investigator-initiated randomized controlled feasibility trial investigating the clinical
mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD. Seventy
patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. The
primary feasibility outcome is the proportion of eligible patients that participate in the study until the end
assessment. Secondary outcome data consists of the fraction of compliant patients in the experimental group and
exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation
symptoms, therapy readiness, quality of life, disability levels, and recovery.
Discussion: This study may help increase our knowledge of possible benefits of, as well as potential barriers to, the
implementation of mHealth tools in the psychiatric sector. It may also provide a cost-efficient means to increase
therapy outcomes and decrease the duration of suffering for PTSD patients in the psychiatric sector.
Trial registration: 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.
Keywords: PTSD, mHealth, Feasibility
OriginalsprogEngelsk
TidsskriftPilot and Feasibility Studies
Vol/bind6
Udgave nummer1
ISSN2055-5784
DOI
StatusUdgivet - 30 jun. 2020

ID: 62048454