Viewing Study NCT02400710



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Study NCT ID: NCT02400710
Status: COMPLETED
Last Update Posted: 2016-02-03
First Post: 2015-03-16

Brief Title: Clinician-Supported PTSD Coach vs Self-Managed PTSD Coach
Sponsor: Syracuse VA Medical Center
Organization: Syracuse VA Medical Center

Study Overview

Official Title: Clinician-Supported PTSD Coach vs Self-Managed PTSD Coach A Pilot Feasibility Trial
Status: COMPLETED
Status Verified Date: 2016-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: PTSD Coach is a mobile application app that aims to teach individuals self-management strategies for symptoms of Post-traumatic Stress Disorder PTSD Despite PTSD Coachs use of evidence-based cognitive behavioral strategies there is still a need to test the effectiveness of the app in managing PTSD symptoms There is research evidence that self-management programs are often underutilized but that clinician contact can increase patient involvement The addition of clinician support may enhance the utilization and effectiveness of the PTSD Coach In Phase 1 the investigators propose to conduct stakeholder interviews with primary care PC and mental health MH leadership staff to investigate barriers and facilitators to implementing Clinician-Supported CS-PTSD Coach to increase the uptake use and impact of PTSD Coach by PC patients The interviews will inform the development of a CS-PTSD Coach protocol and manual that will be used in phase 2 In phase 2 the investigators propose to conduct a feasibility study where 30 20 eligible PC Veterans with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive Self-Managed SM PTSD Coach or CS-PTSD Coach The investigators specific aims are to 1 investigate the feasibility of recruiting and retaining participants and delivering the SM and CS conditions and 2 conduct a preliminary investigation of the efficacy of SM vs CS The investigators predict that CS will lead to greater treatment gains than SM Effect sizes will be generated for the following outcomes a reductions in PTSD depression and general distress and increases in health-related functioning b increases in knowledge about PTSD symptoms PTSD management strategies and patient coping self-efficacy c increases in initiation of tradition PTSD treatments
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None