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Mobile Health Application for Family and Behavioral Health Provider Communication

Primary Purpose

Posttraumatic Stress Disorder, Anger

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Connectd mobile application

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Veterans, Posttraumatic Stress Disorder, Anger, Behavioral Health, Mobile Health Technology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke University, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CBT only

CBT + Connectd mobile health app

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Working Alliance Inventory (Short Form, Therapist)

Documents perspectives of therapist-client relationship

Participant Treatment Participation

Number of weekly sessions attended by participants

Working Alliance Inventory (Client)

Documents perspectives of therapist-client relationship

PTSD Knowledge Scale

Measures general knowledge about PTSD

Zarit Burden Interview

Measures stress felt by caregivers

Secondary Outcome Measures

Dimensions of Anger Reactions

Measure of anger disposition towards others

Clinician-Administered PTSD Scale for DSM5 (CAPS 5)

Assessment of PTSD symptoms

Full Information

NCT ID

NCT02954146

First Posted

October 24, 2016

Last Updated

March 6, 2018

Sponsor

InferLink Corporation

Collaborators

Duke University, University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT02954146

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

March 5, 2018 (Actual)

Study Completion Date

March 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InferLink Corporation

Collaborators

Duke University, University of California, Los Angeles

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder, Anger

Keywords

Veterans, Posttraumatic Stress Disorder, Anger, Behavioral Health, Mobile Health Technology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CBT only

Arm Type

Active Comparator

Arm Description

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

Arm Title

CBT + Connectd mobile health app

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Connectd mobile application

Intervention Description

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 Outcome Measure Information:

Title

Working Alliance Inventory (Short Form, Therapist)

Description

Documents perspectives of therapist-client relationship

Time Frame

12 weeks

Title

Participant Treatment Participation

Description

Number of weekly sessions attended by participants

Time Frame

12 weeks

Title

Working Alliance Inventory (Client)

Description

Documents perspectives of therapist-client relationship

Time Frame

12 weeks

Title

PTSD Knowledge Scale

Description

Measures general knowledge about PTSD

Time Frame

12 weeks

Title

Zarit Burden Interview

Description

Measures stress felt by caregivers

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Dimensions of Anger Reactions

Description

Measure of anger disposition towards others

Time Frame

12 weeks

Title

Clinician-Administered PTSD Scale for DSM5 (CAPS 5)

Description

Assessment of PTSD symptoms

Time Frame

Past month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Elbogen, PhD

Organizational Affiliation

Duke

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Greg Barish, PhD

Organizational Affiliation

InferLink Corporation

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Patricia E Lester, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Study Chair

Facility Information:

Facility Name

Duke University, Department of Psychiatry

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mobile Health Application for Family and Behavioral Health Provider Communication

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