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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 5, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

October 20, 2016
October 24, 2016
December 5, 2018
July 31, 2017
January 1, 2022   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT02943408 on ClinicalTrials.gov Archive Site
  • 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).
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Development of a Patient Centered Mental Health Intervention for Recent Veterans
Development of a Patient Centered Mental Health Intervention for Recent Veterans
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcomes assessors will be blind to participant intervention assignment.
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Depression
  • Anxiety
  • Substance-Related Disorders
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: person-centered mental health intervention
  • 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.
    Intervention: Behavioral: health and wellness
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
Same as current
June 1, 2022
January 1, 2022   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Samantha Hack, PhD (410) 637-1857 samantha.hack@va.gov
United States
 
 
NCT02943408
D2159-W
1IK2RX002159-01A2 ( U.S. NIH Grant/Contract )
No
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
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.
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Samantha Hack, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
VA Office of Research and Development
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP