- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954146
Mobile Health Application for Family and Behavioral Health Provider Communication
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University, Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CBT only
Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management.
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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.
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Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Working Alliance Inventory (Short Form, Therapist)
Time Frame: 12 weeks
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Documents perspectives of therapist-client relationship
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12 weeks
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Participant Treatment Participation
Time Frame: 12 weeks
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Number of weekly sessions attended by participants
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12 weeks
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Working Alliance Inventory (Client)
Time Frame: 12 weeks
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Documents perspectives of therapist-client relationship
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12 weeks
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PTSD Knowledge Scale
Time Frame: 12 weeks
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Measures general knowledge about PTSD
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12 weeks
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Zarit Burden Interview
Time Frame: 12 weeks
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Measures stress felt by caregivers
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dimensions of Anger Reactions
Time Frame: 12 weeks
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Measure of anger disposition towards others
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12 weeks
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Clinician-Administered PTSD Scale for DSM5 (CAPS 5)
Time Frame: Past month
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Assessment of PTSD symptoms
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Past month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric Elbogen, PhD, Duke
- Study Chair: Greg Barish, PhD, InferLink Corporation
- Study Chair: Patricia E Lester, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00069014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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