NCT03862703

PTSD Help - a Randomized Controlled Trial of a PTSD Mobile Health App

Status unknown NA Last updated 3 September 2020

What this trial tests

NA trial testing mHealth intervention, PTSD Help app. in PTSD in 64 participants. Status unknown.

Timeline

14 March 2019

Primary endpoint
1 November 2020

31 July 2021

Quick facts

Lead sponsor	Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	64
Start date	14 March 2019
Primary completion	1 November 2020
Estimated completion	31 July 2021
Sites	1 location across Denmark

Drugs / interventions tested

• mHealth intervention, PTSD Help app.

Conditions studied

• PTSD — all drugs for PTSD →
• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Who can join

18 and older, any sex, with PTSD or Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Due to an increase in PTSD patients seeking treatment in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase the effectiveness of existing treatments for PTSD. mHealth interventions have been shown to be effective in reducing PTSD symptoms with small to moderate effect sizes. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a supplement to therapy may increase treatment outcome. As no studies to date has explored the effects of mHealth interventions in the Danish mental health sector the feasibility and effect of this type of intervention needs testing.

The study's primary hypothesis is that PTSD patients in a Danish psychiatric outpatient setting will want to use a mHealth application as a supplement to care as usual (CAU). The secondary hypothesis is that PTSD patients will benefit from using a mHealth application as a supplement to CAU The study is an investigator-initiated randomized controlled feasibility trial investigating PTSD help combined with CAU compared to CAU for adults with PTSD. Eighty patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. Primary outcome is the ratio of eligible patients that agree to participate in the study and the level of user compliance. Secondary outcome data consists of exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, recovery and rumination.

This study may help increase the investigator's knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the Danish psychiatric sector.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.
   Scharff FB, Lau ME, Riisager LHG, Møller SB, et al · · 2020 · cited 2× · PMID 32617173 · DOI 10.1186/s40814-020-00633-x