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Development of a Patient Centered Mental Health Intervention for Recent Veterans (PCC MH)

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ClinicalTrials.gov Identifier: NCT02943408
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Depression Anxiety Substance-Related Disorders Behavioral: person-centered mental health intervention Behavioral: health and wellness Not Applicable

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 coded Veteran provider encounters and quantitative analysis of functioning from self-report surveys.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will be blind to participant intervention assignment.
Primary Purpose: Treatment
Official Title: Development of a Patient Centered Mental Health Intervention for Recent Veterans
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: person-centered mental health intervention (PCMHI)
We anticipate that the PCMHI will be comprised of three, one-hour sessions offered over three to six weeks, scheduled at the participants' preference. Sessions will be one-on-one and the peer support specialist interventionist.
Behavioral: person-centered mental health intervention
We anticipate that the PCMHI will be comprised of three, one-hour sessions offered over three to six weeks, scheduled at the participants' preference. Sessions will be one-on-one and the peer support specialist interventionist.
Active Comparator: health and wellness
The control condition will be an educational health and wellness intervention for stress related disorders that will match the experimental condition for time and attention. The control condition will be three, one hour, individual sessions covering the symptom cycle, managing stress, and identifying social supports.
Behavioral: health and wellness
The control condition will be an educational health and wellness intervention for stress related disorders that will match the experimental condition for time and attention. The control condition will be three, one hour, individual sessions covering the symptom cycle, managing stress, and identifying social supports.



Primary Outcome Measures :
  1. patient-centered communication [ Time Frame: one day ]
    The Measure of Patient Centered Care is a method for trained raters to assess and quantify recordings of patient-provider encounters. It does not necessitate that the recorded encounters be transcribed for coding.

  2. change in self-assessment of functioning [ Time Frame: 6 months ]
    The Veterans RAND 36-Item Health Survey measures health-related quality of life in 8 domains, 4 of which will be utilized in this study: (1) role limitations due to emotional problems, (2) vitality, (3) social functioning, and (4) mental health. Item response scales differ but are scored with 3- to 6-point scale and are summed to create total and domain scores.

  3. change in self-assessment of functioning [ Time Frame: 6 months ]
    World Health Organization Disability Assessment Schedule 2.0 is a 36-item assessment of health and disability across physical and mental health disorders in both clinical and non-clinical settings/populations. It closely corresponds with the International Classification of Functioning, Disability, and Health (ICF). I will use subscales measuring (1) life activities such as domestic responsibilities and work, and (2) participation in community activities. Items are scored on a 5-point scale (from none to extreme) that are summed to create total and domain scores.


Secondary Outcome Measures :
  1. change in depression and anxiety symptoms [ Time Frame: 6 months ]
    Depression Anxiety Stress Scale is 21 self report items scored on a 4-point Likert scales that range from 0 (not at all) to 4 (applied very much). Depression Anxiety Stress Scales -21 (DASS-21) scores are organized in five clinical levels (normal to extremely severe).

  2. change in PTSD symptoms [ Time Frame: 6 months ]
    PTSD Checklist for DSM-5 is the most current version of the PTSD Check List (PCL), the gold standard of PTSD symptom assessments. Its 20-items use a 5-point Likert scale (0-not at all to 4-extremely) that maps on to the diagnostic criteria outlined in the DSM-5. The PCL-5 is appropriate for both clinical and research purposes and is recommended for monitoring symptom change. The PCL-5 is summed to create a total score. Preliminary validation has established that a 10 point change is clinically significant.

  3. change in alcohol use symptoms [ Time Frame: 6 months ]
    Alcohol Use Disorders Identification Test is a 10-item self-report instrument with 3 subscales: hazardous alcohol use, harmful alcohol use, and dependence symptoms. The items obtain information on the frequency and amount of drinking and alcohol-related problems. Scores on the AUDIT correspond with 4 risk level zones and movement between risk level zones is a clinically significant change.

  4. change in substance use symptoms [ Time Frame: 6 months ]
    Drug Abuse Screening Test (DAST) is a 10 item, yes or no response measure of drug use. The DAST 10 scores are divided into five levels of symptomology and level change is considered clinically significant.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943408


Contacts
Contact: Samantha Hack, PhD (410) 637-1857 samantha.hack@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Julia E Kindred, MS    410-637-1866    julia.kindred@va.gov   
Principal Investigator: Samantha Hack, PhD         
Rehabilitation R&D Service, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21202
Contact: Samantha Hack, PhD    410-637-1857    Samantha.Hack@va.gov   
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD Recruiting
Perry Point, Maryland, United States, 21902
Contact: Samantha Hack, PhD    410-637-1857    Samantha.Hack@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Samantha Hack, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02943408     History of Changes
Other Study ID Numbers: D2159-W
1IK2RX002159-01A2 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final datasets will be maintained locally until enterprise-level resources become available. Final data sets will be made available to the public upon request as outlined in Question 5 above. Specifically, complete person-level data will be provided as either a Limited Dataset or as a de-identified, anonymized dataset depending on the needs of the requester.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Veterans
mental health
Patient-Centered Care

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders