N/A
N=48
Development of a Patient Centered Mental Health Intervention for Recent Veterans
Stress Disorders, Post-Traumatic · Depression · Anxiety · Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02943408 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Role Limitations) Due to Emotional Problems — 50.98; 47.35 score on a scale — p=.90
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- person-centered mental health intervention (Behavioral); health and wellness (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Role Limitations) Due to Emotional Problems |
50.98; 47.35 | .90 |
| PRIMARY Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Vitality) |
29.12; 28.64 | .99 |
| PRIMARY Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Social Functioning) |
46.32; 36.36 | .56 |
| PRIMARY Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Mental Health) |
50.82; 48.55 | .85 |
| PRIMARY World Health Organization Disability Assessment Schedule 2.0 (Change in Self-assessment of Functioning - Household Life Activities) |
41.18; 50 | .43 |
| PRIMARY World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - School/Work Life Activities) |
36.26; 39.52 | .82 |
| PRIMARY World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - Participation in Community Activities) |
41.91; 48.86 | .50 |
| SECONDARY Depression Anxiety Stress Scale-21 (Change in Depression Symptoms) |
7.77; 8.55 | .56 |
| SECONDARY Depression Anxiety Stress Scale-21 (Change in Anxiety Symptoms) |
6.77; 8.23 | .92 |
| SECONDARY PTSD Checklist for DSM-5 (Change in PTSD Symptoms) |
31.65; 38.55 | .65 |
| SECONDARY Alcohol Use Disorders Identification Test (Change in Alcohol Use Symptoms) |
3; 4.36 | .35 |
| SECONDARY Drug Abuse Screening Test (DAST-10) - (Change in Substance Use Symptoms) |
.63; .74 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02943408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.