Development of a Patient Centered Mental Health Intervention for Recent Veterans

Depression Clinical Trial

— PCC MH  

Official title:

Development of a Patient Centered Mental Health Intervention for Recent Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943408
• Other study ID #: D2159-W
• Secondary ID: 1IK2RX002159-01A
• Status: Completed
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress Disorders, Post-Traumatic
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	Rehabilitation R&D Service, Baltimore, MD	Baltimore	Maryland
United States	Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD	Perry Point	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Depression Anxiety Stress Scale-21 (Change in Depression Symptoms)	Depression Anxiety Stress Scale is 21 self report items scored on a 4-point Likert scale that ranges from 0 (not at all) to 3 (applied very much). It has three subscales: depression (7 items with a possible score from 0 to 21), anxiety (7 items with a possible score from 0 to 21), and stress (7 items with a possible score from 0 to 21). Higher scores indicate greater symptomology.	6 months
Secondary	Depression Anxiety Stress Scale-21 (Change in Anxiety Symptoms)	Depression Anxiety Stress Scale is 21 self report items scored on a 4-point Likert scale that ranges from 0 (not at all) to 3 (applied very much). It has three subscales: depression (7 items with a possible score from 0 to 21), anxiety (7 items with a possible score from 0 to 21), and stress (7 items with a possible score from 0 to 21). Higher scores indicate greater symptomology.	6 months
Secondary	PTSD Checklist for DSM-5 (Change in PTSD Symptoms)	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 with a possible range of 0 to 80. A score of 31-33 or higher is indicative of a provisional diagnosis of PTSD and preliminary validation has established that a 10 point change is clinically significant.	6 months
Secondary	Alcohol Use Disorders Identification Test (Change in Alcohol Use Symptoms)	Alcohol Use Disorders Identification Test is a 10-item self-report instrument with each item scored on a scale of 0-4 for a total possible score of 0 to 40. The items obtain information on the frequency and amount of drinking and alcohol-related problems. A score of 8 or more is associated with harmful or hazardous drinking.	6 months
Secondary	Drug Abuse Screening Test (DAST-10) - (Change in Substance Use Symptoms)	Drug Abuse Screening Test (DAST) is a 10 item, yes or no response measure of drug use. The possible scores range from 0 to 10. The DAST 10 scores are divided into five levels of symptomology (0 No problems reported; 1-2 Low; 3-5 Moderate; 6-8 Substantial; 9-10 Severe) and level change is considered clinically significant.	6 months