Stress Disorders, Post-TraumaticPhase 1NCT02486705
Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
A Phase 1 study testing PTSD Family Coach Full and PTSD Family Coach Basic in people with Stress Disorders, Post-Traumatic, run by VA Palo Alto Health Care System at 1 site in United States.
Trial summary
The proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder (PTSD). 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
- What is being tested?
- PTSD Family Coach Full and PTSD Family Coach Basic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 1
- 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
- currently living with a Veteran with significant PTSD symptoms
- age 18 or older
- own an iPhone, iPad or other iOS compatible device
- currently experiencing at least moderate symptoms of stress
Who cannot join
- currently enrolled in another study related to PTSD
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Menlo Park, California, 94025
About this study
Official title: Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
The proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder (PTSD). The primary objective of the proposed study is to assess whether family members of veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app increases family members' self-efficacy and their ability to manage their own life stress, which may in part be the result of living with someone who has PTSD.
Read the detailed description
PTSD Family Coach is a mobile phone app for family members of individuals with PTSD. This application provides:
- education about PTSD
- a self-assessment tool measuring life stress
- self-management skills to address acute distress and stress
- direct connection to support and
- information about VA and community resources for family members of individuals with PTSD
From this research, the investigators wish to learn whether family members of someone with PTSD find the PTSD Family Coach to be satisfactory and feasible to use. The investigators would also like to know if use of the app increases family members' knowledge of PTSD, and its treatment, and their ability to manage their own life stress, which may in part be the result of living with a Veteran with PTSD.
Currently, there are very few resources for family members of Veterans with PTSD. If this research demonstrates that PTSD Family Coach is a promising tool for family members, it has the potential to address a tremendous unmet need using a very cost-effective, scalable solution.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- PTSD Family Coach Full, PTSD Family Coach Basic
- Keywords
- ptsd, family, caregiver, burden
- 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 Family Coach FullBehavioural
Also called PTSD Family Coach app- full version
PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information, support resources, tools for coping with caregiver-related stress, and tools for self-monitoring stress symptoms.
PTSD Family Coach BasicBehavioural
Also called PTSD Family Coach app- basic version
PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,
| Study group | Role | What they receive |
|---|---|---|
| PTSD Family Coach Basic | Active comparator | PTSD Coach basic provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD and additional support resources. Receives: Behavioral: PTSD Family Coach Basic |
| PTSD Family Coach Full | Experimental | PTSD Family Coach full provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD, additional support resources, tools for coping with caregiving-related stress, and tools for self-monitoring stress symptoms. Receives: Behavioral: PTSD Family Coach Full |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden (Montgomery Burden Interview)
Measured: 1 month
Stress (Perceived Stress Scale)
Measured: 1 month
Use of PTSD Family Coach Mobile App (Study-Specific Survey)
Measured: 1 month
Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)
Measured: 1 month
Depression (PHQ-8)
Measured: 1 month
Anxiety (GAD)
Measured: 1 month
Secondary outcomes (5)
Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)
Measured: 1 month
Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)
Measured: 1 month
Social Constraints (Social Constraints Scale)
Measured: 1 month
Partner Self-Efficacy (Study-Specific Measure)
Measured: 1 month
Veteran Interest in Treatment for PTSD (Study-Specific Measure)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 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
- NCT02486705
- Sponsor's protocol ID
- 28147
- Status last verified
- Sep 2015
- First submitted
- 21 Apr 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
van Stolk-Cooke K, Wielgosz J, Hallenbeck HW, Chang A, Rosen C, Owen J, Kuhn E. The PTSD Family Coach App in Veteran Family Members: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Jan 5;7:e42053. doi: 10.2196/42053.
PubMed 36602852
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
- ClinicalTrials.gov ID
- NCT02486705
- Acronym / sponsor ID
- 28147
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- ptsd, family, caregiver, burden
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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 proposed pilot study is designed to test the feasibility, acceptability, and potential effectiveness of a mobile phone application (app) developed by the VA National Center for PTSD (VA NCPTSD) for use by family members of those with Posttraumatic Stress Disorder (PTSD). The primary objective of the proposed study is to assess whether family members of veterans with PTSD find the PTSD Family Coach app to be satisfactory and feasible to use. Secondary objectives are to determine if use of the app increases family members' self-efficacy and their ability to manage their own life stress, which may in part be the result of living with someone who has PTSD.
Detailed description
PTSD Family Coach is a mobile phone app for family members of individuals with PTSD. This application provides:
- education about PTSD
- a self-assessment tool measuring life stress
- self-management skills to address acute distress and stress
- direct connection to support and
- information about VA and community resources for family members of individuals with PTSD
From this research, the investigators wish to learn whether family members of someone with PTSD find the PTSD Family Coach to be satisfactory and feasible to use. The investigators would also like to know if use of the app increases family members' knowledge of PTSD, and its treatment, and their ability to manage their own life stress, which may in part be the result of living with a Veteran with PTSD.
Currently, there are very few resources for family members of Veterans with PTSD. If this research demonstrates that PTSD Family Coach is a promising tool for family members, it has the potential to address a tremendous unmet need using a very cost-effective, scalable solution.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD Family Coach Basic | Active comparator | Behavioral: PTSD Family Coach BasicPTSD Coach basic provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD and additional support resources. |
| PTSD Family Coach Full | Experimental | Behavioral: PTSD Family Coach FullPTSD Family Coach full provides an iOS mobile app with extensive information about caregiving for family members of those with PTSD, additional support resources, tools for coping with caregiving-related stress, and tools for self-monitoring stress symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently living with a Veteran with significant PTSD symptoms
- age 18 or older
- own an iPhone, iPad or other iOS compatible device
- currently experiencing at least moderate symptoms of stress
Key exclusion criteria (1 listed)
- currently enrolled in another study related to 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 |
|---|---|---|
| PTSD Family Coach FullAlso: PTSD Family Coach app- full versionPTSD Family Coach mobile app is an iOS mobile phone application designed to provide information, support resources, tools for coping with caregiver-related stress, and tools for self-monitoring stress symptoms. | Behavioural | PTSD Family Coach Full |
| PTSD Family Coach BasicAlso: PTSD Family Coach app- basic versionPTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources, | Behavioural | PTSD Family Coach Basic |
Primary outcome
Caregiver Burden (Montgomery Burden Interview)
Time frame: 1 month
Stress (Perceived Stress Scale)
Time frame: 1 month
Use of PTSD Family Coach Mobile App (Study-Specific Survey)
Time frame: 1 month
Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)
Time frame: 1 month
Depression (PHQ-8)
Time frame: 1 month
Anxiety (GAD)
Time frame: 1 month
5 secondary outcomes
Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)
Time frame: 1 month
Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)
Time frame: 1 month
Social Constraints (Social Constraints Scale)
Time frame: 1 month
Partner Self-Efficacy (Study-Specific Measure)
Time frame: 1 month
Veteran Interest in Treatment for PTSD (Study-Specific Measure)
Time frame: 1 month
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 7 Sep 2015.
- Derived from this study: PubMed 36602852van Stolk-Cooke K, Wielgosz J, Hallenbeck HW, Chang A, Rosen C, Owen J, Kuhn E. The PTSD Family Coach App in Veteran Family Members: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Jan 5;7:e42053. doi: 10.2196/42053.
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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 Phase 1 study testing PTSD Family Coach Full and PTSD Family Coach Basic in people with Stress Disorders, Post-Traumatic, 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 7 Sep 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Caregiver Burden (Montgomery Burden Interview) (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486705, which also lists 1 linked publication.
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 7 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.