NCT02954146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

October 24, 2016

Last Update Submit

March 6, 2018

Conditions

Posttraumatic Stress DisorderAnger

Keywords

VeteransPosttraumatic Stress DisorderAngerBehavioral HealthMobile Health Technology

Outcome Measures

Primary Outcomes (5)

  • Working Alliance Inventory (Short Form, Therapist)

    Documents perspectives of therapist-client relationship

    12 weeks

  • Participant Treatment Participation

    Number of weekly sessions attended by participants

    12 weeks

  • Working Alliance Inventory (Client)

    Documents perspectives of therapist-client relationship

    12 weeks

  • PTSD Knowledge Scale

    Measures general knowledge about PTSD

    12 weeks

  • Zarit Burden Interview

    Measures stress felt by caregivers

    12 weeks

Secondary Outcomes (2)

  • Dimensions of Anger Reactions

    12 weeks

  • Clinician-Administered PTSD Scale for DSM5 (CAPS 5)

    Past month

Study Arms (2)

CBT only

ACTIVE COMPARATOR

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

Behavioral: Connectd mobile application

CBT + Connectd mobile health app

EXPERIMENTAL

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.

Behavioral: Connectd mobile application

Interventions

Connectd mobile applicationBEHAVIORAL

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.

CBT + Connectd mobile health appCBT only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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;

You may not qualify if:

  • \- Is currently participating in, or is scheduled to participate in a manualized psychosocial treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University, Department of Psychiatry

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Eric Elbogen, PhD

    Duke

    PRINCIPAL INVESTIGATOR

  • Greg Barish, PhD

    InferLink Corporation

    STUDY CHAIR

  • Patricia E Lester, MD

    University of California, Los Angeles

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 3, 2016

Study Start

November 1, 2016

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

March 8, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)