Mobile Health Application for Family and Behavioral Health Provider Communication

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-03-05

Brief Summary

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The purpose of this study is to examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.

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Detailed Description

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Purpose: we will examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.

Participants: (N=100) 50 veterans who have served in the military since October 2001 and have PTSD with anger problems; and 50 collateral family members/close friends above the age of 18.

Procedures (methods): All Veterans with PTSD will receive a 12 session standard CBT for anger. Veterans in the intervention group will additionally receive instructions for using SupportTeam with a family member or friend that will provide data for the CBT clinician. Veterans in the control group will receive the CBT sessions, but will not receive the SupportTeam mobile application.

Conditions

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Posttraumatic Stress Disorder Anger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT only

Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management.

Group Type ACTIVE_COMPARATOR

Connectd mobile application

Intervention Type BEHAVIORAL

Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review. The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes. In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.

CBT + Connectd mobile health app

Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT) sessions for anger management. In addition, veterans in this group will also receive instructions for using Connectd mobile health app with a family member or friend that will provide data for the CBT clinician.

Group Type EXPERIMENTAL

Connectd mobile application

Intervention Type BEHAVIORAL

Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review. The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes. In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.

Interventions

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Connectd mobile application

Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review. The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes. In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

For Veteran:

* Age 18 or older
* Served in a branch of the US military since October, 2001
* Meets DSM-5 criteria for current PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);
* Reports at least one episode of anger or irritability in the past week;
* Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
* Has a family member or friend who also has and uses a smartphone with a data plan and agrees to participate in the study.
* Is able and willing to attend 12 weekly sessions at Duke Psychiatry offices within normal business hours (M-F 8:00-5:00)

For Collateral:

* 18 years old or older
* Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;