Clinical Trials Directory

Trials / Completed

CompletedNCT02400710

Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach

Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach: A Pilot Feasibility Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Syracuse VA Medical Center · Federal
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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 Coach's 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALClinician-Supported PTSD CoachBrief primary care-based intervention provided by a mental health clinician who is located in primary care.
BEHAVIORALSelf-Managed PTSD CoachOne 10 minute session explaining how to use the PTSD Coach mobile app.

Timeline

Start date
2013-04-01
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2015-03-27
Last updated
2016-02-03
Results posted
2016-02-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02400710. Inclusion in this directory is not an endorsement.