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

NCT ID: NCT02486705

Last Updated: 2015-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Disorders, Post-Traumatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

PTSD Family Coach Basic

Intervention Type BEHAVIORAL

PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,

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.

Group Type EXPERIMENTAL

PTSD Family Coach Full

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

PTSD Family Coach Basic

PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PTSD Family Coach app- full version PTSD Family Coach app- basic version

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jason Owen

Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Palo Alto Health Care System

Menlo Park, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36602852 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

28147

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Training for PTSD
NCT03316196 COMPLETED NA