Development of a Patient Centered Mental Health Intervention for Recent Veterans



Status:Recruiting
Conditions:Anxiety, Anxiety, Depression, Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:12/7/2018
Start Date:July 31, 2017
End Date:June 1, 2022
Contact:Samantha Hack, PhD
Email:samantha.hack@va.gov
Phone:(410) 637-1857

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Recent Veterans of the OIF/OEF/OND conflicts are presenting in VA care with high rates of:
PTSD, depression, anxiety, and alcohol abuse, reporting significant difficulties with
community reintegration, and dropping out of mental health care at high rates. Surveys of
recent Veterans show that Veterans want the VA to provide mental health care tailored to
their concerns and reintegration priorities. The VA is committed to providing personalized,
proactive, patient centered care (PCC); but little research or intervention development has
been done on PCC in mental health care settings and preliminary research indicates Veterans
may lack the skills and knowledge to be active partners in PCC. This study aims to examine
PCC behaviors in VA mental health care and, informed by this data, develop a brief patient
centered mental health intervention that will help recent Veterans take the lead in their
care personalization and support their functional recovery. Results from this study will
demonstrate the acceptability, feasibility, and preliminary efficacy of this intervention.

Project Background: The term "recent Veterans" refers to Veterans who served in the military
operations Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn.
Almost 60% of recent Veterans who received VA care have been diagnosed with a mental health
disorder, most commonly posttraumatic stress disorder (32%), depressive disorders (26%),
anxiety disorders (25%), and substance abuse (13%). The research literature consistently
confirms that recent Veterans with stress-related mental health disorders experience
impairment in functional domains of health (overcoming and managing disease), purpose
(meaningful daily activities and participation in society), and community (positive
relationships and social networks).

Project Objectives: The proposed research will characterize patient centered care in VA
mental health care and produce a brief patient centered intervention that will empower
Veterans to lead and personalize their mental health care in support of their functional
recovery. In Aim 1 of this research the investigators will characterize rates of providers'
and recent Veterans' (n=30) participation in the four components of PCC, as well as barriers
and facilitators of each PCC component, to inform development of a brief patient centered
mental health intervention in Aim 2. In Aim 2 the investigators will develop a brief patient
centered mental health intervention for recent Veterans experiencing stress-related mental
health disorders and conduct a pre-pilot demonstration (n=10) to assess acceptability. This
intervention will be informed by data collected in Aim 1 and developed using an iterative
process of discussion with and input from recent Veterans, VA mental health providers, peer
specialists, and researchers. Finally in Aim 3 the investigators will test the feasibility
and preliminary efficacy of the brief intervention by conducting a randomized controlled
trial with 48 recent Veterans with stress-related mental health disorders.

Project Methods: In Aim 1 data will be collected at one time point using surveys and a
recording of a Veteran provider encounter which will be coded to quantify Veteran and
provider patient centered care behaviors. Intervention development in Aim 2 will be led by a
multi-stakeholder Advisory Panel and further developed using Veteran focus groups.
Acceptability will be demonstrated via qualitative interviews following a pre-pilot
demonstration project with 10 Veteran participants. In Aim 3 data will be collected at
baseline, post-RCT participation, and 3 month and 6 month follow-up. Feasibility will be
assessed with study administration data on engagement and participation in the intervention
and preliminary efficacy will be evaluated via coded Veteran provider encounters and
quantitative analysis of functioning from self-report surveys.

Inclusion Criteria:

Per medical record review:

- military service in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation
New Dawn (OIF/OEF/OND)

- Veteran accessed mental health care (MHC) service at designated study site for the
first time in the last 6 months OR the first time in the last 6 months after at least
a one year gap in mental health care

- have a diagnosis of PTSD (309.81), major depressive disorder (296.20-296.23,
296.30-296.33), other specified or unspecified depressive disorder (311), social
anxiety disorder (300.23), panic disorder (300.01), generalized anxiety disorder
(300.02), other specified or unspecified anxiety disorder (300.09, 300.00), substance
use disorders (303.90, 304.00, 304.10, 304.30), Unspecified Trauma and
Stressor-Related Disorder (309.9), Other Specified Trauma and Stressor-Related
Disorder (309.89), or Adjustment Disorder (309.20- 309.25)

- age between 18 and 65

- sufficient clinical stability to participate as deemed by a treatment provider

- Veteran consents to having one mental health encounter recorded and coded

- Veteran's relevant provider consents to having one mental health encounter recorded
and coded

Exclusion Criteria:

Per medical record review:

- current diagnosis of a psychotic disorder meeting criteria established by the VA
Serious Mental Illness Treatment, Research, and Evaluation Center (SMITREC):

- schizophrenic disorders (295.0-295.9)

- affective psychoses (296.0-296.1, 296.4-296.8)

- or major depression with psychotic features (296.24, 296.34)
We found this trial at
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Baltimore, Maryland 21201
Principal Investigator: Samantha Hack, PhD
Phone: 410-637-1866
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