PTSDNCT02445196
PTSD Coach App Evaluation
A study testing PTSD Coach and Smartphone in people with PTSD, run by Craig Barr Taylor.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- PTSD Coach and Smartphone
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to give informed consent.
- Is currently receiving mental health treatment.
- Currently participating in other PTSD-related research studies
About this study
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
- Being tested
- PTSD Coach, Smartphone
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSD CoachBehavioural
PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
SmartphoneDevice
All participants must have a smartphone, either apple or android.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PTSD Coach; Device: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline to Posttreatment (3 months)
Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)
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.
Measured: Baseline to Posttreatment (3 months)
Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)
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.
Measured: Baseline to Posttreatment (3 months)
Sustained 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.
Measured: Postreatment to 3-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Barr Taylor
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Sponsor-investigator, Craig Barr Taylor, Stanford University
- Investigators
- C Barr Taylor, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445196
- Sponsor's protocol ID
- 22977
- Status last verified
- Dec 2016
- First submitted
- 11 May 2015
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTSD Coach App Evaluation
- ClinicalTrials.gov ID
- NCT02445196
- Acronym / sponsor ID
- 22977
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Craig Barr TaylorUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD Coach | Experimental | Behavioral: PTSD Coach, Device: SmartphoneSubjects 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. |
| Waitlist Control | Active comparator | Behavioral: PTSD Coach, Device: SmartphoneSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Unable to give informed consent.
- Is currently receiving mental health treatment.
- Currently participating in other PTSD-related research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTSD CoachPTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD. | Behavioural | PTSD Coach, Waitlist Control |
| SmartphoneAll participants must have a smartphone, either apple or android. | Device | PTSD Coach, Waitlist Control |
Primary outcome
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.
4 secondary outcomes
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)
Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)
Time frame: Baseline to Posttreatment (3 months)
Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)
Time frame: Baseline to Posttreatment (3 months)
Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)
Time frame: Postreatment to 3-month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C Barr Taylor, M.D. principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing PTSD Coach and Smartphone in people with PTSD, run by Craig Barr Taylor.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL) (time frame: Baseline to Posttreatment (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.