Mobile Health Application for Family and Behavioral Health Provider Communication

Posttraumatic Stress Disorder Clinical Trial

Official title:

Mobile Health Application for Family and Behavioral Health Provider Communication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954146
• Other study ID #: Pro00069014
• Status: Completed
• Phase: N/A
• First received: October 24, 2016
• Last updated: March 6, 2018
• Start date: November 2016
• Est. completion date: March 5, 2018

Study information

• Verified date: March 2018
• Source: InferLink Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anger
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke University, Department of Psychiatry	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
InferLink Corporation	Duke University, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working Alliance Inventory (Short Form, Therapist)	Documents perspectives of therapist-client relationship	12 weeks
Primary	Participant Treatment Participation	Number of weekly sessions attended by participants	12 weeks
Primary	Working Alliance Inventory (Client)	Documents perspectives of therapist-client relationship	12 weeks
Primary	PTSD Knowledge Scale	Measures general knowledge about PTSD	12 weeks
Primary	Zarit Burden Interview	Measures stress felt by caregivers	12 weeks
Secondary	Dimensions of Anger Reactions	Measure of anger disposition towards others	12 weeks
Secondary	Clinician-Administered PTSD Scale for DSM5 (CAPS 5)	Assessment of PTSD symptoms	Past month