PTSD Coach App Evaluation

NCT02445196 | Completed Results

• 1 other identifier: 22977
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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 (PCL) 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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)

  PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, \& Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.

  Baseline to Posttreatment (3 months)

Secondary Outcomes (4)

• Change in Subject Coping Self-efficacy Measured by a Questionnaire Assessing Confidence in Managing Core Symptoms of PTSD Addressed in the Intervention

  Baseline to Posttreatment (3 months)

• Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)

  Baseline to Posttreatment (3 months)

• Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)

  Baseline to Posttreatment (3 months)

• Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)

  Postreatment to 3-month Follow-up

Study Arms (2)

PTSD Coach

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.

Behavioral: PTSD Coach; Device: Smartphone

Waitlist Control

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.

Behavioral: PTSD Coach; Device: Smartphone

Interventions

PTSD Coach BEHAVIORAL

PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.

PTSD Coach; Waitlist Control

Smartphone DEVICE

All participants must have a smartphone, either apple or android.

PTSD Coach; Waitlist Control

Eligibility Criteria

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

You may qualify if:

• 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.
• Significant PTSD symptoms. Total PTSD Checklist Score ≥ 35.
• Have a smartphone or smart device that can download apps (iPhone, iPod touch, iPad, or android phone or tablet).
• English is the primary language.
• Available for the next 6 months to participate in the study and use smart device.

You may not qualify if:

• Unable to give informed consent.
• Is currently receiving mental health treatment.
• Currently participating in other PTSD-related research studies

Sponsors & Collaborators

• Craig Barr Taylor: lead
• VA Palo Alto Health Care System: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. C. Barr Taylor
• Organization: Stanford University

btaylor@stanford.edu

415-987-1810

Study Officials

• C Barr Taylor, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 15, 2015
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2016-12