Clinical trial NCT02943408: Development of a Patient Centered Mental Health Intervention for Recent Veterans
Official title: Development of a Patient Centered Mental Health Intervention for Recent Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Depression
Anxiety
Substance-Related Disorders
Keywords: Veterans
mental health
Patient-Centered Care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 quantitative analysis of functioning from self-report surveys.

Note: Measure of Patient Centered Care (Patient-centered Communication) was removed as a measure. The MPCC requires recording a patient-provider encounter and coding it. When the pandemic occurred previous methods of recording encounters and physically bringing an approved recording device to the provider's office prior to the session, was no longer viable. Investigators had to suspend recording until approved technology guidance was provided. When a means was identified it was so cumbersome no providers agreed to record.

Eligibility criteria: 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)

Primary outcomes:
measure: Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Role Limitations) Due to Emotional Problems
timeFrame: 6 months
measure: Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Vitality)
timeFrame: 6 months
measure: Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Social Functioning)
timeFrame: 6 months
measure: Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Mental Health)
timeFrame: 6 months
measure: World Health Organization Disability Assessment Schedule 2.0 (Change in Self-assessment of Functioning - Household Life Activities)
timeFrame: 6 months
measure: World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - School/Work Life Activities)
timeFrame: 6 months
measure: World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - Participation in Community Activities)
timeFrame: 6 months
Secondary outcomes:
measure: Depression Anxiety Stress Scale-21 (Change in Depression Symptoms)
timeFrame: 6 months
measure: Depression Anxiety Stress Scale-21 (Change in Anxiety Symptoms)
timeFrame: 6 months
measure: PTSD Checklist for DSM-5 (Change in PTSD Symptoms)
timeFrame: 6 months
measure: Alcohol Use Disorders Identification Test (Change in Alcohol Use Symptoms)
timeFrame: 6 months
measure: Drug Abuse Screening Test (DAST-10) - (Change in Substance Use Symptoms)
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: Baltimore
country: United States
facility: Rehabilitation R&D Service, Baltimore, MD
state: Maryland
city: Perry Point
country: United States
facility: Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Samantha Hack, PhD
role: PRINCIPAL_INVESTIGATOR
References: