Mobile Health Application for Family and Behavioral Health Provider Communication

InferLink

Status: Completed

Conditions: Posttraumatic Stress Disorder; Anger

Treatments: Behavioral: Connectd mobile application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02954146

Pro00069014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

CBT only

Active Comparator group

Description:

Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management.

Treatment:

Behavioral: Connectd mobile application

CBT + Connectd mobile health app

Experimental group

Description:

Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT) sessions for anger management. In addition, veterans in this group will also receive instructions for using Connectd mobile health app with a family member or friend that will provide data for the CBT clinician.

Treatment:

Behavioral: Connectd mobile application