Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Pilot Evaluation of PTSD Family Coach, a Mobile Phone App for Family Members of Individuals With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486705
• Other study ID #: 28147
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2015
• Last updated: September 3, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• PTSD Family Coach Full
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 Basic
PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Menlo Park	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Burden (Montgomery Burden Interview)		1 month	No
Primary	Stress (Perceived Stress Scale)		1 month	No
Primary	Use of PTSD Family Coach Mobile App (Study-Specific Survey)		1 month	No
Primary	Satisfaction with PTSD Family Coach Mobile App (Study-Specific Survey)		1 month	No
Primary	Depression (PHQ-8)		1 month	No
Primary	Anxiety (GAD)		1 month	No
Secondary	Stigma Associated with Seeking Mental Health Care (Study-Specific Measure)		1 month	No
Secondary	Perceived Benefits of Mental Health Treatment for PTSD (Study-Specific Measure)		1 month	No
Secondary	Social Constraints (Social Constraints Scale)		1 month	No
Secondary	Partner Self-Efficacy (Study-Specific Measure)		1 month	No
Secondary	Veteran Interest in Treatment for PTSD (Study-Specific Measure)		1 month	No