Stress Disorders, Post-TraumaticNCT03199742
Evaluation of a Mobile Phone App for Veterans With PTSD
A study testing Personalized App Coaching and Active Comparator in people with Stress Disorders, Post-Traumatic and Veterans, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone apps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Veterans
- What is being tested?
- Personalized App Coaching and Active Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- U.S. military Veteran
- age 18 or older
- previously diagnosed with PTSD
- own an iPhone or iPad device
Who cannot join
- no previous history of PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System Menlo Park Division
Menlo Park, California, 94025
About this study
The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone apps. The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.
Read the detailed description
Participants will receive access to the mobile app "PTSD Coach". Participants will be randomized (by computerized coin flip) to one of two versions of the mobile app. All versions of the app will provide comprehensive information and tools for managing trauma symptoms, but one version of the app will provide personalized, confidential coaching messages delivered by either a Veteran peer or clinical psychologist. Participants will be asked to complete an online survey before using the mobile phone application and again 8 weeks later. Participants will be provided with the option to complete a telephone interview after 8 weeks of using the mobile phone application. To be eligible, participants must be a U.S. military Veteran, age 18 or older, have received a previous diagnosis of PTSD, and own an iPhone or iPad device.
- Conditions
- Stress Disorders, Post-Traumatic, Veterans
- Being tested
- Personalized App Coaching, Active Comparator
- 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.
Personalized App CoachingBehavioural
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study. Participants will be provided with feedback about recent progress \& use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
Active ComparatorBehavioural
Mobile phone application providing extensive information about PTSD and treatment, tools for managing PTSD symptoms, self-monitoring using the PTSD Checklist, and resources for obtaining support.
| Study group | Role | What they receive |
|---|---|---|
| PTSD Coach with no Coaching | Active comparator | Participants will receive the PTSD coach mobile app. Receives: Behavioral: Active Comparator |
| PTSD Coach with Peer Coaching | Experimental | Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer. Receives: Behavioral: Personalized App Coaching |
| PTSD Coach with Clinician coaching | Experimental | Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist. Receives: Behavioral: Personalized App Coaching |
| PTSD Coach with Automated Coaching | Experimental | Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks. Receives: Behavioral: Personalized App Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist 5
Measures symptoms of post-traumatic stress disorder
Measured: 8 weeks
Functional Well-Being
Measures functional well-being of Veterans across a number of domains, including self-care, romantic relationships, work, family functioning, and parenting. Subscale scores will be aggregated to create a summary score for this measure.
Measured: 8 weeks
Engagement with the Application
Objectively-measured engagement with the intervention (# sessions)
Measured: 8 weeks
Secondary outcomes (2)
Self-Efficacy for Coping
Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.
Measured: 8 weeks
Perceived Helpfulness of Intervention
How helpful the intervention was for providing information and tools for managing PTSD.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Dec 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Model description
- Participants are randomized to receive one of 2 forms of the mobile phone application being tested in this study: with and without personalized coaching. Among those who receive coaching, participants will receive either peer-based coaching messages, clinician-based coaching messages, or automated messages.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jason Owen, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199742
- Sponsor's protocol ID
- IRB-31533
- Status last verified
- Apr 2019
- First submitted
- 20 Jun 2017
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Phone App for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT03199742
- Acronym / sponsor ID
- IRB-31533
- Conditions
- Stress Disorders, Post-Traumatic, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone apps. The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.
Detailed description
Participants will receive access to the mobile app "PTSD Coach". Participants will be randomized (by computerized coin flip) to one of two versions of the mobile app. All versions of the app will provide comprehensive information and tools for managing trauma symptoms, but one version of the app will provide personalized, confidential coaching messages delivered by either a Veteran peer or clinical psychologist. Participants will be asked to complete an online survey before using the mobile phone application and again 8 weeks later. Participants will be provided with the option to complete a telephone interview after 8 weeks of using the mobile phone application. To be eligible, participants must be a U.S. military Veteran, age 18 or older, have received a previous diagnosis of PTSD, and own an iPhone or iPad device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants are randomized to receive one of 2 forms of the mobile phone application being tested in this study: with and without personalized coaching. Among those who receive coaching, participants will receive either peer-based coaching messages, clinician-based coaching messages, or automated messages.
| Arm | Type | Receives |
|---|---|---|
| PTSD Coach with no Coaching | Active comparator | Behavioral: Active ComparatorParticipants will receive the PTSD coach mobile app. |
| PTSD Coach with Peer Coaching | Experimental | Behavioral: Personalized App CoachingParticipants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer. |
| PTSD Coach with Clinician coaching | Experimental | Behavioral: Personalized App CoachingParticipants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist. |
| PTSD Coach with Automated Coaching | Experimental | Behavioral: Personalized App CoachingParticipants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- U.S. military Veteran
- age 18 or older
- previously diagnosed with PTSD
- own an iPhone or iPad device
Key exclusion criteria (1 listed)
- no previous history of PTSD
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 |
|---|---|---|
| Personalized App CoachingAll coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study. Participants will be provided with feedback about recent progress \& use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days. | Behavioural | PTSD Coach with Automated Coaching, PTSD Coach with Clinician coaching, PTSD Coach with Peer Coaching |
| Active ComparatorMobile phone application providing extensive information about PTSD and treatment, tools for managing PTSD symptoms, self-monitoring using the PTSD Checklist, and resources for obtaining support. | Behavioural | PTSD Coach with no Coaching |
Primary outcome
PTSD Checklist 5
Time frame: 8 weeks
Measures symptoms of post-traumatic stress disorder
Functional Well-Being
Time frame: 8 weeks
Measures functional well-being of Veterans across a number of domains, including self-care, romantic relationships, work, family functioning, and parenting. Subscale scores will be aggregated to create a summary score for this measure.
Engagement with the Application
Time frame: 8 weeks
Objectively-measured engagement with the intervention (# sessions)
2 secondary outcomes
Self-Efficacy for Coping
Time frame: 8 weeks
Perceived Helpfulness of Intervention
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized App Coaching and Active Comparator in people with Stress Disorders, Post-Traumatic and Veterans, run by VA Palo Alto Health Care System at 1 site in United States.
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 4 inclusion and 1 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PTSD Checklist 5 (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 26 Apr 2019.