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Mobile Health Application for Family and Behavioral Health Provider Communication

Mobile Health Application for Family and Behavioral Health Provider Communication

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02954146
Enrollment
120
Registered
2016-11-03
Start date
2016-11-30
Completion date
2018-03-05
Last updated
2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anger, Posttraumatic Stress Disorder

Keywords

Veterans, Posttraumatic Stress Disorder, Anger, Behavioral Health, Mobile Health Technology

Brief summary

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

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.

Interventions

BEHAVIORALConnectd 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.

Sponsors

Duke University
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
InferLink Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Participant Treatment Participation12 weeksNumber of weekly sessions attended by participants
PTSD Knowledge Scale12 weeksMeasures general knowledge about PTSD
Zarit Burden Interview12 weeksMeasures stress felt by caregivers
Working Alliance Inventory (Short Form, Therapist)12 weeksDocuments perspectives of therapist-client relationship
Working Alliance Inventory (Client)12 weeksDocuments perspectives of therapist-client relationship

Secondary

MeasureTime frameDescription
Clinician-Administered PTSD Scale for DSM5 (CAPS 5)Past monthAssessment of PTSD symptoms
Dimensions of Anger Reactions12 weeksMeasure of anger disposition towards others

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026