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

Study Overview
=================
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 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.

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

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Behavioral: Clinician-Supported PTSD Coach
* Behavioral: Self-Managed PTSD Coach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in primary care at the Syracuse VAMC, Significant PTSD symptoms. Total PTSD Checklist Score ≥ 40. Exclusion Criteria: Gross cognitive impairment (as measured by the Blessed Orientation-Memory-Concentration; BOMC) Suicide attempt or intent to commit suicide in the last two months (as measured by the Columbia- Suicide Severity Rating Scale Psychotherapy or mental health counseling for PTSD in the last two months that was received outside of VA primary care A new psychotropic medication or a change in dose of a psychotropic medication for PTSD in the last two months that was received outside of VA primary care Intent to begin PTSD treatment in specialty care

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinician-Supported PTSD Coach<br>Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own. | Behavioral: Clinician-Supported PTSD Coach<br>* Brief primary care-based intervention provided by a mental health clinician who is located in primary care.<br>|
| Active Comparator: Self-Managed PTSD Coach<br>One in-person 10-minute session that provides instructions on how to use the PTSD Coach app. | Behavioral: Self-Managed PTSD Coach<br>* One 10 minute session explaining how to use the PTSD Coach mobile app.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist-Specific | Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record | Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention. | 16 weeks |