Clinical trial NCT02486705: Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
Official title: Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stress Disorders, Post-Traumatic
Keywords: ptsd
family
caregiver
burden
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2015-07-01
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver Burden (Montgomery Burden Interview)
timeFrame: 1 month
measure: Stress (Perceived Stress Scale)
timeFrame: 1 month
measure: Use of PTSD Family Coach Mobile App (Study-Specific Survey)
timeFrame: 1 month
measure: Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)
timeFrame: 1 month
measure: Depression (PHQ-8)
timeFrame: 1 month
measure: Anxiety (GAD)
timeFrame: 1 month
Secondary outcomes:
measure: Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)
timeFrame: 1 month
measure: Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)
timeFrame: 1 month
measure: Social Constraints (Social Constraints Scale)
timeFrame: 1 month
measure: Partner Self-Efficacy (Study-Specific Measure)
timeFrame: 1 month
measure: Veteran Interest in Treatment for PTSD (Study-Specific Measure)
timeFrame: 1 month
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References: