search
Back to results

Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Referral Management System
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Post-traumatic Stress Disorder, Evidence-Based Psychotherapy, Treatment Engagement, Cognitive Behavioral Therapy, Implementation Science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Team Red primary care patients,
  • have a score of at least 44 on PCL-S and
  • able to give informed consent.

Exclusion Criteria:

None

Sites / Locations

  • Syracuse VA Medical Center, Syracuse, NY

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Team Red Primary Care

Arm Description

Eligible patients will receive the Referral Management System in primary care

Outcomes

Primary Outcome Measures

Engagement in Evidence-based Psychotherapy for PTSD
Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.

Secondary Outcome Measures

PTSD Checklist-Specific
Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.
Patient Health Questionnaire-9 Item
9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.

Full Information

First Posted
November 7, 2013
Last Updated
November 10, 2015
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01984515
Brief Title
Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans
Official Title
Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to implement an evidence-based Referral Management System that will address patient and system-level barriers to the uptake of evidence-based psychotherapy for PTSD by Veterans Affairs primary care patients.
Detailed Description
Within the Veteran's Health Administration (VHA), primary care (PC) patients with PTSD have low rates of engagement in evidence-based psychotherapy (EBP) for PTSD. Low engagement rates are due to a variety of patient-level (e.g., belief that treatment will not be helpful, stigma) and system-level barriers (e.g., lack of tracking of referral process, knowledge gaps on how to manage PTSD). We propose to conduct a pilot hybrid effectiveness- implementation study to implement an evidence-based Referral Management System (RMS) that will address patient and system-level barriers to the uptake of EBP for PTSD by VHA primary care patients. RMS will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me"). This CBT intervention has been previously found to be effective for increasing treatment engagement with Veterans with PTSD. Depending on Veteran preference, it will be delivered by the PC-MHI provider within the PC clinic or a Behavioral Health Lab (BHL) care manager by phone. RMS will be initiated by PACT staff and will address system-level barriers by having a BHL technician track the progress of RMS referrals and contact Veterans who have not followed thought on their chosen referral options. PACT staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD. Our aims, implementation strategy, data collection, and analyses will be guided by established strategies. The Consolidated Framework for Implementation Research (CFIR) will identify organization variables. RE-AIM will investigate program uptake and patient/ system-level impact. An Implementation Mapping approach will guide our implementation strategy. We propose to conduct this study in 3 phases. Phase 1 includes interviews with PC and MH leadership about the relevance of CFIR constructs to RMS implementation and a meeting with PACT staff to train them on RMS and gather their input on how RMS should be adapted to their clinic. A PC medical provider will serve as a clinical champion who is knowledgeable, communicative, and a leader in promoting RMS among his/her peers. Phase 2 consists of implementing RMS for 6 months in one Syracuse PC clinic and then measuring RE-AIM outcomes. Some RE-AIM outcomes compared participants who received RMS to those who did not receive RMS in a historical control group. Phase 3 involves meeting with PACT and MH Leadership and PACT staff to share a formal report of study results and gather information about potential barriers and facilitators to long-term maintenance and future expansion of RMS within the CFIR framework. An expert national stakeholder panel will also be convened to guide development of a SDP that will investigate multi-VISN implementation. Our long-term aim of this line of research is to increase implementation of evidence-based psychotherapy for PTSD by getting more primary care patients with PTSD to engage in treatment. Our Specific Aims for this Rapid Response Project are to: 1. Assess and improve the feasibility of implementing RMS in PC-MHI/PACT settings 1A. Diagnose organizational and staff-level barriers and facilitators to implementing RMS. 1B. Adapt RMS for the local context based on information gathered about barriers and facilitators. 2. Evaluate initial impact of implementing RMS in PC-MHI/PACT settings. Assess impact of RMS on RE-AIM measures of Reach, Efficacy/Effectiveness, Adoption, Implementation and Maintenance 3. Refine implementation strategy based on study findings for planned efforts to spread RMS to additional VISNs in a QUERI Phase 2 Service-Directed Project (SDP) to follow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Post-traumatic Stress Disorder, Evidence-Based Psychotherapy, Treatment Engagement, Cognitive Behavioral Therapy, Implementation Science

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Team Red Primary Care
Arm Type
Experimental
Arm Description
Eligible patients will receive the Referral Management System in primary care
Intervention Type
Behavioral
Intervention Name(s)
Referral Management System
Intervention Description
Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.
Primary Outcome Measure Information:
Title
Engagement in Evidence-based Psychotherapy for PTSD
Description
Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.
Time Frame
From initiation of the Referral Management System to 6 months after initiation
Secondary Outcome Measure Information:
Title
PTSD Checklist-Specific
Description
Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.
Time Frame
Referral Management Initiation, 1 month post initiation, 3 months post initiation
Title
Patient Health Questionnaire-9 Item
Description
9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.
Time Frame
Referral Management Initiation, 1 month post initiation, 3 months post initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Team Red primary care patients, have a score of at least 44 on PCL-S and able to give informed consent. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Possemato, PhD
Organizational Affiliation
Syracuse VA Medical Center, Syracuse, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans

We'll reach out to this number within 24 hrs