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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02445196
Other study ID # 22977
Secondary ID
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


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
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