PTSD Coach App Evaluation

PTSD Clinical Trial

Official title:

PTSD Coach App Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02445196
• Other study ID #: 22977
• Status: Active, not recruiting
• Phase: N/A
• First received: May 11, 2015
• Last updated: April 18, 2016
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

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

Device:
• Smartphone
All participants must have a smartphone, either apple or android.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Craig Barr Taylor	National Center for PTSD, VA Palo Alto Health Care System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)		Baseline to 3-month post-intervention	No
Secondary	Change in subject coping self-efficacy measured by a questionnaire assessing confidence in managing core symptoms of PTSD addressed in the intervention		Baseline to 3-month post-intervention, and 3-month follow-up	No
Secondary	Change in interpersonal functioning measured by a brief Inventory of Psychosocial Functioning (IPF7)		Baseline to 3-month post-intervention, and 3-month follow-up	No
Secondary	Change in depression symptoms measured by the Patient Health Questionnaire (PHQ8)		Baseline to 3-month post-intervention, and 3-month follow-up	No
Secondary	Sustained change in PTSD symptoms measured by the Post Traumatic Stress Disorder Checklist for DSM-5 (PCL5)		3-month post-intervention to 3-month follow-up	No