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OpenTrials
Completed

NCT Number: NCT02954146

Mobile Health Application for Family and Behavioral Health Provider Communication

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University, Department of Psychiatry

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Connectd mobile application

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.

Primary outcomes

  1. Working Alliance Inventory (Short Form, Therapist)

    Time frame: 12 weeks

    Documents perspectives of therapist-client relationship

  2. Participant Treatment Participation

    Time frame: 12 weeks

    Number of weekly sessions attended by participants

  3. Working Alliance Inventory (Client)

    Time frame: 12 weeks

    Documents perspectives of therapist-client relationship

  4. PTSD Knowledge Scale

    Time frame: 12 weeks

    Measures general knowledge about PTSD

  5. Zarit Burden Interview

    Time frame: 12 weeks

    Measures stress felt by caregivers

Secondary outcomes

  1. Dimensions of Anger Reactions

    Time frame: 12 weeks

    Measure of anger disposition towards others

  2. Clinician-Administered PTSD Scale for DSM5 (CAPS 5)

    Time frame: Past month

    Assessment of PTSD symptoms

Sponsors and collaborators

Lead sponsor

InferLink Corporation

Industry

Collaborators

  • Duke University
  • University of California, Los Angeles

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 3, 2016
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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