Mobile Health Application for Family and Behavioral Health Provider Communication

Study Overview
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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.

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.

Official Title
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Mobile Health Application for Family and Behavioral Health Provider Communication

Conditions
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Posttraumatic Stress Disorder, Anger

Intervention / Treatment
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* Behavioral: Connectd mobile application


Participation Criteria
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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; Has a family member or friend who meets the veteran inclusion criteria and agrees to participate in the study. Exclusion Criteria, Veteran: - Is currently participating in, or is scheduled to participate in a manualized psychosocial treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT only<br>Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management. | Behavioral: Connectd mobile application<br>* 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.<br>|
| Experimental: CBT + Connectd mobile health app<br>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. | Behavioral: Connectd mobile application<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working Alliance Inventory (Short Form, Therapist) | Documents perspectives of therapist-client relationship | 12 weeks | 
| Participant Treatment Participation | Number of weekly sessions attended by participants | 12 weeks | 
| Working Alliance Inventory (Client) | Documents perspectives of therapist-client relationship | 12 weeks | 
| PTSD Knowledge Scale | Measures general knowledge about PTSD | 12 weeks | 
| Zarit Burden Interview | Measures stress felt by caregivers | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimensions of Anger Reactions | Measure of anger disposition towards others | 12 weeks | 
| Clinician-Administered PTSD Scale for DSM5 (CAPS 5) | Assessment of PTSD symptoms | Past month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, Posttraumatic Stress Disorder, Anger, Behavioral Health, Mobile Health Technology