Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital

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

Research output: Contribution to journalJournal articlepeer-review

  1. The Short Version of the Metacognitive Anger Processing Scale (MAP-SV) - initial psychometric testing

    Research output: Contribution to journalJournal articlepeer-review

  2. Treatment of difficult-to-treat depression - clinical guideline for selected interventions

    Research output: Contribution to journalReviewpeer-review

  3. Improving the precision of depression diagnosis in general practice: a cluster-randomized trial

    Research output: Contribution to journalJournal articlepeer-review

View graph of relations

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 (ID: 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.

Original languageEnglish
Article number92
JournalPilot and Feasibility Studies
Issue number1
Pages (from-to)92
Publication statusPublished - 30 Jun 2020

    Research areas

  • Health Sciences - Feasibility, PTSD, mHealth
  • Feasibility, mHealth, PTSD

ID: 62048454