Evaluation of a Mobile Phone App for Veterans With PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Evaluation of a Mobile Phone App for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199742
• Other study ID #: IRB-31533
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone apps. The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.

Description:

Participants will receive access to the mobile app "PTSD Coach". Participants will be randomized (by computerized coin flip) to one of two versions of the mobile app. All versions of the app will provide comprehensive information and tools for managing trauma symptoms, but one version of the app will provide personalized, confidential coaching messages delivered by either a Veteran peer or clinical psychologist. Participants will be asked to complete an online survey before using the mobile phone application and again 8 weeks later. Participants will be provided with the option to complete a telephone interview after 8 weeks of using the mobile phone application. To be eligible, participants must be a U.S. military Veteran, age 18 or older, have received a previous diagnosis of PTSD, and own an iPhone or iPad device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• U.S. military Veteran

• age 18 or older

• previously diagnosed with PTSD

• own an iPhone or iPad device

Exclusion Criteria:

• no previous history of PTSD

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Veterans

Intervention

Behavioral:
• Personalized App Coaching
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study. Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
• Active Comparator
Mobile phone application providing extensive information about PTSD and treatment, tools for managing PTSD symptoms, self-monitoring using the PTSD Checklist, and resources for obtaining support.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System Menlo Park Division	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	PTSD Checklist 5	Measures symptoms of post-traumatic stress disorder	8 weeks
Primary	Functional Well-Being	Measures functional well-being of Veterans across a number of domains, including self-care, romantic relationships, work, family functioning, and parenting. Subscale scores will be aggregated to create a summary score for this measure.	8 weeks
Primary	Engagement with the Application	Objectively-measured engagement with the intervention (# sessions)	8 weeks
Secondary	Self-Efficacy for Coping	Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.	8 weeks
Secondary	Perceived Helpfulness of Intervention	How helpful the intervention was for providing information and tools for managing PTSD.	8 weeks