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

NCT03862703 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-09-03

No results posted yet for this study

Summary

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.

Conditions

  • PTSD
  • Post Traumatic Stress Disorder

Interventions

DEVICE

mHealth intervention, PTSD Help app.

Experimental group will receive the app, PTSD Help.

Sponsors & Collaborators

  • The Danish Victims Fund

    collaborator OTHER_GOV

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Stine B. Moeller, Ph.D. · Head of Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2020-11-01
Completion
2021-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03862703 on ClinicalTrials.gov