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

Primary Purpose

PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinician-Supported PTSD Coach
Self-Managed PTSD Coach
Sponsored by
Syracuse VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Enrolled in primary care at the Syracuse VAMC,
  2. Significant PTSD symptoms. Total PTSD Checklist Score ≥ 40.

Exclusion Criteria:

  1. Gross cognitive impairment (as measured by the Blessed Orientation-Memory-Concentration; BOMC)
  2. Suicide attempt or intent to commit suicide in the last two months (as measured by the Columbia- Suicide Severity Rating Scale
  3. Psychotherapy or mental health counseling for PTSD in the last two months that was received outside of VA primary care
  4. 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
  5. Intent to begin PTSD treatment in specialty care

Sites / Locations

  • Syracuse VMAC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clinician-Supported PTSD Coach

Self-Managed PTSD Coach

Arm Description

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.

One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 16, 2015
Last Updated
January 4, 2016
Sponsor
Syracuse VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02400710
Brief Title
Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach
Official Title
Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach: A Pilot Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinician-Supported PTSD Coach
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Managed PTSD Coach
Arm Type
Active Comparator
Arm Description
One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Intervention Type
Behavioral
Intervention Name(s)
Clinician-Supported PTSD Coach
Intervention Description
Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
Intervention Type
Behavioral
Intervention Name(s)
Self-Managed PTSD Coach
Intervention Description
One 10 minute session explaining how to use the PTSD Coach mobile app.
Primary Outcome Measure Information:
Title
PTSD Checklist-Specific
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record
Description
Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Possemato, Ph.D.
Organizational Affiliation
Syracuse VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse VMAC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

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

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