Clinical trial NCT02954146: Mobile Health Application for Family and Behavioral Health Provider Communication
Official title: Mobile Health Application for Family and Behavioral Health Provider Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Anger
Keywords: Veterans
Posttraumatic Stress Disorder
Anger
Behavioral Health
Mobile Health Technology
Lead sponsor: InferLink Corporation
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: University of California, Los Angeles
First posted: 2016-11-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Working Alliance Inventory (Short Form, Therapist)
timeFrame: 12 weeks
measure: Participant Treatment Participation
timeFrame: 12 weeks
measure: Working Alliance Inventory (Client)
timeFrame: 12 weeks
measure: PTSD Knowledge Scale
timeFrame: 12 weeks
measure: Zarit Burden Interview
timeFrame: 12 weeks
Secondary outcomes:
measure: Dimensions of Anger Reactions
timeFrame: 12 weeks
measure: Clinician-Administered PTSD Scale for DSM5 (CAPS 5)
timeFrame: Past month
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University, Department of Psychiatry
state: North Carolina
Study officials:
affiliation: Duke
name: Eric Elbogen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: InferLink Corporation
name: Greg Barish, PhD
role: STUDY_CHAIR
affiliation: University of California, Los Angeles
name: Patricia E Lester, MD
role: STUDY_CHAIR
References: