Mobile Health Application for Family and Behavioral Health Provider Communication

Not Applicable

Completed

• Conditions: Anger; Posttraumatic Stress Disorder

• Registration Number: NCT02954146
• Lead Sponsor: InferLink Corporation

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.

Study Timeline

• Study First Submitted: 2016-10-24
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Status Verified: 2018-03
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University, Department of Psychiatry; 🇺🇸 Durham, North Carolina, United States