Clinical trial NCT02445196: PTSD Coach App Evaluation
Official title: PTSD Coach App Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
First posted: 2015-05-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)
timeFrame: Baseline to Posttreatment (3 months)
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
timeFrame: Baseline to Posttreatment (3 months)
measure: Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)
timeFrame: Baseline to Posttreatment (3 months)
measure: Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)
timeFrame: Baseline to Posttreatment (3 months)
measure: Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)
timeFrame: Postreatment to 3-month Follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: C Barr Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References: