- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02486705
Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Menlo Park, California, United States, 94025
- VA Palo Alto Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- currently enrolled in another study related to PTSD
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PTSD Family Coach Basic
PTSD 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 mobile app is an iOS mobile phone application designed to provide information and support resources,
Other Names:
|
Experimental: PTSD Family Coach Full
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Caregiver Burden (Montgomery Burden Interview)
Time Frame: 1 month
|
1 month
|
Stress (Perceived Stress Scale)
Time Frame: 1 month
|
1 month
|
Use of PTSD Family Coach Mobile App (Study-Specific Survey)
Time Frame: 1 month
|
1 month
|
Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)
Time Frame: 1 month
|
1 month
|
Depression (PHQ-8)
Time Frame: 1 month
|
1 month
|
Anxiety (GAD)
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)
Time Frame: 1 month
|
1 month
|
Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)
Time Frame: 1 month
|
1 month
|
Social Constraints (Social Constraints Scale)
Time Frame: 1 month
|
1 month
|
Partner Self-Efficacy (Study-Specific Measure)
Time Frame: 1 month
|
1 month
|
Veteran Interest in Treatment for PTSD (Study-Specific Measure)
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Disorders, Post-Traumatic
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH); Oregon Clinical...CompletedPost-Traumatic Stress DisordersUnited States
-
US Department of Veterans AffairsEmory UniversityWithdrawnPost-Traumatic Stress Disorders
-
University of KonstanzGerman Research Foundation; NGO vivo e.V.; GTZ-German Technical Cooperation,... and other collaboratorsCompletedPost-Traumatic Stress DisordersSri Lanka
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesRecruitingPost-Traumatic Stress DisorderUnited States
-
Johns Hopkins UniversityWithdrawnPost-Traumatic Stress Disorder
Clinical Trials on PTSD Family Coach Basic
-
Syracuse VA Medical CenterCompleted
-
Jewish General HospitalCanadian Institutes of Health Research (CIHR)Unknown
-
University of PittsburghPalo Alto Veterans Institute for ResearchCompletedChronic Pain | Posttraumatic Stress Disorder | Acute Pain Due to TraumaUnited States
-
Uppsala UniversityCompletedPosttraumatic StressSweden
-
VA Office of Research and DevelopmentSoutheast Louisiana Veterans Health Care SystemCompletedStress Disorders, Post-TraumaticUnited States
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress DisorderUnited States
-
Drexel UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingObesity | OverweightUnited States
-
University of BremenRWTH Aachen University; Bielefeld University; Medical School Berlin; Karlsruhe...Recruiting
-
University of MichiganNational Institute of Mental Health (NIMH)Recruiting