Overview

This trial is active, not recruiting.

Condition ptsd
Treatments ptsd coach, smartphone
Sponsor Craig Barr Taylor
Collaborator National Center for PTSD, VA Palo Alto Health Care System
Start date February 2014
End date September 2015
Trial size 120 participants
Trial identifier NCT02445196, 22977

Summary

PTSD Coach is a mobile application (app) that aims to teach individuals self-management strategies for symptoms of Post-traumatic Stress Disorder (PTSD). PTSD is a major public health concern. Although effective treatments exist, affected individuals face many barriers to receiving traditional care. As smartphones are now carried by more than half of the U.S. population, they have the potential to overcome many of these barriers by delivering self-help interventions on apps. Despite PTSD Coach's use of evidence-based cognitive behavioral strategies there is still a need to test the effectiveness of the app in managing PTSD symptoms. This controlled, two-arm, randomized (1:1) trial will evaluate the efficacy, feasibility and acceptability of PTSD Coach to reduce PTSD symptoms in a community sample of trauma survivors with PTSD symptoms. After completing an eligibility phone screen or online screen, individuals who score a 35 or above on the PTSD Checklist for DSM-5 (PCL-5) and consent will complete a baseline assessment and then be randomized to the PTSD Coach app condition or a waitlist control group. Additionally, those assigned to the PTSD Coach intervention will be instructed to download a research version of the app, called PTSD Explorer, that enables passive and objective monitoring of app use. Each individual will be reassessed at post-intervention (3 months) and follow-up (3 months later, or 6 months after completing baseline). The investigators predict that those using the PTSD Coach app will demonstrate a significant and sustained reduction in PTSD symptoms and increase in patient coping self-efficacy compared to the waitlist control group. The investigators will explore if there is a relationship between levels of engagement and PTSD symptom change.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.
ptsd coach
PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
smartphone
All participants must have a smartphone, either apple or android.
(Active Comparator)
Subjects assigned to this condition are told: "You have been randomly assigned to Group 2, the group that does not use the app." Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.
ptsd coach
PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
smartphone
All participants must have a smartphone, either apple or android.

Primary Outcomes

Measure
Change in PTSD symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)
time frame: Baseline to 3-month post-intervention

Secondary Outcomes

Measure
Change in subject coping self-efficacy measured by a questionnaire assessing confidence in managing core symptoms of PTSD addressed in the intervention
time frame: Baseline to 3-month post-intervention, and 3-month follow-up
Change in interpersonal functioning measured by a brief Inventory of Psychosocial Functioning (IPF7)
time frame: Baseline to 3-month post-intervention, and 3-month follow-up
Change in depression symptoms measured by the Patient Health Questionnaire (PHQ8)
time frame: Baseline to 3-month post-intervention, and 3-month follow-up
Sustained change in PTSD symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)
time frame: 3-month post-intervention to 3-month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Experienced or witnessed an extremely traumatic event that involved actual or threatened death or serious injury to you or someone else. Event must have occurred more than 1 month ago. 2. Significant PTSD symptoms. Total PTSD Checklist Score ≥ 35. 3. Have a smartphone or smart device that can download apps (iPhone, iPod touch, iPad, or android phone or tablet). 4. English is the primary language. 5. Available for the next 6 months to participate in the study and use smart device. Exclusion Criteria: 1. Unable to give informed consent. 2. Is currently receiving mental health treatment. 3. Currently participating in other PTSD-related research studies

Additional Information

Official title PTSD Coach App Evaluation
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Stanford University.