Stress Disorders, Post-TraumaticPCC MHNCT02943408
Development of a Patient Centered Mental Health Intervention for Recent Veterans
A study testing person-centered mental health intervention and health and wellness in people with Stress Disorders, Post-Traumatic and Depression, run by VA Office of Research and Development at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depression, Anxiety
- What is being tested?
- person-centered mental health intervention and health and wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jul 2017to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, 21202
Perry Point VA Medical Center VA Maryland Health Care System, Perry Point, MD
Perry Point, Maryland, 21902
About this study
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.
Read the 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 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.
- Being tested
- person-centered mental health intervention, health and wellness
- Keywords
- Veterans, mental health, Patient-Centered Care
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
person-centered mental health interventionBehavioural
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 wellnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| person-centered mental health intervention (PCMHI) | Experimental | 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. Receives: Behavioral: person-centered mental health intervention |
| health and wellness | Active comparator | 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. Receives: Behavioral: health and wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start31 Jul 2017
- Primary completion1 Jan 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Samantha Hack, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943408
- Sponsor's protocol ID
- D2159-W
- Other IDs
- 1IK2RX002159-01A2
- Acronym
- PCC MH
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2016
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient Centered Mental Health Intervention for Recent Veterans
- ClinicalTrials.gov ID
- NCT02943408
- Acronym / sponsor ID
- PCC MH / D2159-W
- Keywords
- Veterans, mental health, Patient-Centered Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 26 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| person-centered mental health intervention (PCMHI) | Experimental | Behavioral: person-centered mental health interventionWe 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 comparator | Behavioral: health and wellnessThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- current diagnosis of a psychotic disorder meeting criteria established by the VA Serious Mental Illness Treatment, Research, and Evaluation Center (SMITREC):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| person-centered mental health interventionWe 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. | Behavioural | person-centered mental health intervention (PCMHI) |
| health and wellnessThe 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. | Behavioural | health and wellness |
Primary outcome
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Role Limitations) Due to Emotional Problems
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. Scores range from 0 to 100 with higher scores indicating better functioning.
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Vitality)
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. Scores range from 0 to 100 with higher scores indicating better functioning.
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Social 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. Scores range from 0 to 100 with higher scores indicating better functioning.
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Mental Health)
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. Scores range from 0 to 100 with higher scores indicating better functioning.
World Health Organization Disability Assessment Schedule 2.0 (Change in Self-assessment of Functioning - Household Life Activities)
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). 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.
World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - School/Work Life Activities)
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). 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.
World Health Organization Disability Assessment Schedule 2.0 (Changes in Self-assessment of Functioning - Participation in Community Activities)
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). 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.
5 secondary outcomes
Depression Anxiety Stress Scale-21 (Change in Depression Symptoms)
Time frame: 6 months
Depression Anxiety Stress Scale-21 (Change in Anxiety Symptoms)
Time frame: 6 months
PTSD Checklist for DSM-5 (Change in PTSD Symptoms)
Time frame: 6 months
Alcohol Use Disorders Identification Test (Change in Alcohol Use Symptoms)
Time frame: 6 months
Drug Abuse Screening Test (DAST-10) - (Change in Substance Use Symptoms)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Stress Disorders, Post-Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Hack, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing person-centered mental health intervention and health and wellness in people with Stress Disorders, Post-Traumatic and Depression, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veterans RAND 36-Item Health Survey (Change in Self-assessment of Functioning - Role Limitations) Due to Emotional Problems (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.