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Completed

NCT Number: NCT02445196

PTSD Coach App Evaluation

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

PTSD Coach

Behavioral

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

smartphone

Device

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

Primary outcomes

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

    Time frame: Baseline to Posttreatment (3 months)

    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.

Secondary outcomes

  1. 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 Posttreatment (3 months)

    PTSD symptom coping SE was assessed with a 9-item self-report measure developed for the study following Bandura's guidelines (Bandura, 2006). Items assess confidence in managing PTSD symptoms and reaching out for support on a scale from 0 (cannot do at all) to 100 (highly certain can do). The average score provides an overall measure of SE with higher scores reflecting greater self-efficacy coping with PTSD symptoms. Cronbach's alpha at baseline was .87.

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

    Time frame: Baseline to Posttreatment (3 months)

    Psychosocial functioning was measured using the Brief Inventory of Psychosocial Functioning (B-IPF; Erb, Kearns, Bovin et al., 2015), a 7-item self-report measure. Items are rated on how much trouble the respondent had in the past month in relationships or other important areas of functioning (e.g., work, training or education) on a scale ranging from 0 (not at all) to 6 (very much). An average of applicable items provides an index of psychosocial functioning, with higher scores reflecting more poorer psychosocial functioning. Cronbach's alpha at baseline was .82.

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

    Time frame: Baseline to Posttreatment (3 months)

    Depression was assessed with the Patient Health Questionnaire depression scale (PHQ-8; Kroenke et al., 2009), an 8-item self-report measure of depression with evidence showing its ability to measure depression symptom severity and potential diagnosis. Items are rated on how much the symptom bothered the respondent in the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 24, with higher scores indicating more severe depression symptoms. Cronbach's alpha at baseline was .87.

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

    Time frame: Postreatment to 3-month Follow-up

    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.

Sponsors and collaborators

Lead sponsor

Craig Barr Taylor

Other

Collaborators

  • VA Palo Alto Health Care System

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 15, 2015
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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