NCT03199742

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

June 20, 2017

Last Update Submit

April 24, 2019

Conditions

Stress Disorders, Post-TraumaticVeterans

Outcome Measures

Primary Outcomes (3)

  • PTSD Checklist 5

    Measures symptoms of post-traumatic stress disorder

    8 weeks

  • 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

  • Engagement with the Application

    Objectively-measured engagement with the intervention (# sessions)

    8 weeks

Secondary Outcomes (2)

  • Self-Efficacy for Coping

    8 weeks

  • Perceived Helpfulness of Intervention

    8 weeks

Study Arms (4)

PTSD Coach with no Coaching

ACTIVE COMPARATOR

Participants will receive the PTSD coach mobile app.

Behavioral: Active Comparator

PTSD Coach with Peer Coaching

EXPERIMENTAL

Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.

Behavioral: Personalized App Coaching

PTSD Coach with Clinician coaching

EXPERIMENTAL

Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.

Behavioral: Personalized App Coaching

PTSD Coach with Automated Coaching

EXPERIMENTAL

Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.

Behavioral: Personalized App Coaching

Interventions

Personalized App CoachingBEHAVIORAL

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.

PTSD Coach with Automated CoachingPTSD Coach with Clinician coachingPTSD Coach with Peer Coaching
Active ComparatorBEHAVIORAL

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.

PTSD Coach with no Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • U.S. military Veteran
  • age 18 or older
  • previously diagnosed with PTSD
  • own an iPhone or iPad device

You may not qualify if:

  • no previous history of PTSD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System Menlo Park Division

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized to receive one of 2 forms of the mobile phone application being tested in this study: with and without personalized coaching. Among those who receive coaching, participants will receive either peer-based coaching messages, clinician-based coaching messages, or automated messages.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 27, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)