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

NCT03862703 | Unknown

• 1 other identifier: MHSCRDenmarkPTSDhelp
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Randomization ratio

  Ratio of eligible patients that can be randomized

  40 weeks

• compliance with intervention

  Fraction of patients that used the intervention continously until the end of the study

  34 weeks

Secondary Outcomes (9)

• PTSD Checklist for DSM-V

  1 month

• Dissociative Symptoms Scale

  1 week

• the Symptom Checklist-10

  2 weeks

• WHO-5

  2 weeks

• INSPIRE

  2 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

PTSD Help intervention combined with care as usual.

Device: mHealth intervention, PTSD Help app.

Control group

NO INTERVENTION

Care as usual.

Interventions

mHealth intervention, PTSD Help app. DEVICE

Experimental group will receive the app, PTSD Help.

Also known as: Care as usual.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years old.
• Fulfil the DSM-5 PTSD diagnosis criteria.
• Be referred to PTSD care package treatment (Danske regioner, pakkeforløb for PTSD, 2017)
• Have access to a smartphone with iOS (version 10 or higher) or Android (version 5.0.1. or higher)
• Provide informed consent.

You may not qualify if:

• Suicidal risk
• Ongoing episode of bipolar disease or psychotic disorder
• Current abuse of alcohol or drugs
• Inability to understand and/or read Danish
• Concurrent psychiatric or psychological treatment of PTSD outside of MHS-CRD.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• The Danish Victims Fund: collaborator

Study Sites (1)

Psykoterapeutisk Center Stolpegaard

Copenhagen, Gentofte, 2820, Denmark

Location

Related Publications (1)

• Scharff FB, Lau ME, Riisager LHG, Moller SB, Salimi ML, Gondan M, Folke S. The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial. Pilot Feasibility Stud. 2020 Jun 30;6:92. doi: 10.1186/s40814-020-00633-x. eCollection 2020.

  PMID: 32617173 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Stine B. Moeller, Ph.D.

  Head of Research Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: March 14, 2019
• Primary Completion: November 1, 2020
• Study Completion: July 31, 2021
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)