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

September 3, 2015 updated by: Jason Owen, VA Palo Alto Health Care System

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

242

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Menlo Park, California, United States, 94025
        • VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: PTSD Family Coach Basic
PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,
Other Names:
  • PTSD Family Coach app- basic version
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.
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.
Other Names:
  • PTSD Family Coach app- full version

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

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

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.

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