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Clinical Trials/NCT02954146
NCT02954146
Completed
Not Applicable

Mobile Health Application for Family and Behavioral Health Provider Communication

InferLink Corporation1 site in 1 country120 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
InferLink Corporation
Enrollment
120
Locations
1
Primary Endpoint
Working Alliance Inventory (Short Form, Therapist)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
March 5, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
InferLink Corporation
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Working Alliance Inventory (Short Form, Therapist)

Time Frame: 12 weeks

Documents perspectives of therapist-client relationship

Participant Treatment Participation

Time Frame: 12 weeks

Number of weekly sessions attended by participants

Zarit Burden Interview

Time Frame: 12 weeks

Measures stress felt by caregivers

Working Alliance Inventory (Client)

Time Frame: 12 weeks

Documents perspectives of therapist-client relationship

PTSD Knowledge Scale

Time Frame: 12 weeks

Measures general knowledge about PTSD

Secondary Outcomes

  • Dimensions of Anger Reactions(12 weeks)
  • Clinician-Administered PTSD Scale for DSM5 (CAPS 5)(Past month)

Study Sites (1)

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