MedPath

Mobile Health Application for Family and Behavioral Health Provider Communication

Not Applicable
Completed
Conditions
Anger
Posttraumatic Stress Disorder
Interventions
Behavioral: Connectd mobile application
Registration Number
NCT02954146
Lead Sponsor
InferLink Corporation
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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.
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CBT onlyConnectd mobile applicationVeterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management.
CBT + Connectd mobile health appConnectd mobile applicationVeterans 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.
Primary Outcome Measures
NameTimeMethod
Working Alliance Inventory (Short Form, Therapist)12 weeks

Documents perspectives of therapist-client relationship

Participant Treatment Participation12 weeks

Number of weekly sessions attended by participants

Zarit Burden Interview12 weeks

Measures stress felt by caregivers

Working Alliance Inventory (Client)12 weeks

Documents perspectives of therapist-client relationship

PTSD Knowledge Scale12 weeks

Measures general knowledge about PTSD

Secondary Outcome Measures
NameTimeMethod
Dimensions of Anger Reactions12 weeks

Measure of anger disposition towards others

Clinician-Administered PTSD Scale for DSM5 (CAPS 5)Past month

Assessment of PTSD symptoms

Trial Locations

Locations (1)

Duke University, Department of Psychiatry

🇺🇸

Durham, North Carolina, United States

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