Development of a Patient Centered Mental Health Intervention for Recent Veterans
PCC MH
2 other identifiers
interventional
48
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedStudy Start
First participant enrolled
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedResults Posted
Study results publicly available
December 26, 2023
CompletedDecember 26, 2023
December 1, 2023
4.4 years
October 20, 2016
January 10, 2023
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Role Limitations) Due to Emotional Problems
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. Scores range from 0 to 100 with higher scores indicating better functioning.
6 months
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Vitality)
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. Scores range from 0 to 100 with higher scores indicating better functioning.
6 months
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Social Functioning)
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. Scores range from 0 to 100 with higher scores indicating better functioning.
6 months
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Mental Health)
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. Scores range from 0 to 100 with higher scores indicating better functioning.
6 months
World Health Organization Disability Assessment Schedule 2.0 (Change in Self-assessment of Functioning - Household Life Activities)
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). Subscales measuring (1) life activities such as domestic responsibilities, (2) life activities such as school and work, and (3) participation in community activities. Items are scored on a 0-100 scale. Lower scores indicate less disability.
6 months
World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - School/Work Life Activities)
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). Subscales measuring (1) life activities such as domestic responsibilities, (2) life activities such as school and work, and (3) participation in community activities. Items are scored on a 0-100 scale. Lower scores indicate less disability.
6 months
World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - Participation in Community Activities)
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). Subscales measuring (1) life activities such as domestic responsibilities, (2) life activities such as school and work, and (3) participation in community activities. Items are scored on a 0-100 scale. Lower scores indicate less disability.
6 months
Secondary Outcomes (5)
Depression Anxiety Stress Scale-21 (Change in Depression Symptoms)
6 months
Depression Anxiety Stress Scale-21 (Change in Anxiety Symptoms)
6 months
PTSD Checklist for DSM-5 (Change in PTSD Symptoms)
6 months
Alcohol Use Disorders Identification Test (Change in Alcohol Use Symptoms)
6 months
Drug Abuse Screening Test (DAST-10) - (Change in Substance Use Symptoms)
6 months
Study Arms (2)
person-centered mental health intervention (PCMHI)
EXPERIMENTALWe 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.
health and wellness
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, 21202, United States
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, 21902, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
* This was a pilot randomized controlled trial so the sample size is small. * Approximately one third of the way through recruitment and randomization the COVID-19 pandemic began. This caused disruption to the data collection process and required the interventions to transition from in-person to telehealth platforms. We were not able to record patient-provider encounters to code with the Measure of Patient Centered Communication. Therefore, no results for that measure are reported.
Results Point of Contact
- Title
- Dr. Samantha Hack
- Organization
- Veterans Affairs Rocky Mountain (VISN 19) Mental Illness Research Education and Clinical Center (MIRECC)
Study Officials
- PRINCIPAL INVESTIGATOR
Samantha Hack, PhD
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessors will be blind to participant intervention assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 24, 2016
Study Start
July 31, 2017
Primary Completion
January 1, 2022
Study Completion
June 1, 2022
Last Updated
December 26, 2023
Results First Posted
December 26, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
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.