跳至主要内容
临床试验/NCT02954146
NCT02954146已完成不适用

Mobile Health Application for Family and Behavioral Health Provider Communication

InferLink Corporation2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Working Alliance Inventory (Short Form, Therapist)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Working Alliance Inventory (Short Form, Therapist)

时间窗: 12 weeks

Documents perspectives of therapist-client relationship

Participant Treatment Participation

时间窗: 12 weeks

Number of weekly sessions attended by participants

Zarit Burden Interview

时间窗: 12 weeks

Measures stress felt by caregivers

Working Alliance Inventory (Client)

时间窗: 12 weeks

Documents perspectives of therapist-client relationship

PTSD Knowledge Scale

时间窗: 12 weeks

Measures general knowledge about PTSD

次要结局

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

研究者

发起方
InferLink Corporation
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验