Serious Mental IllnessMARSNCT01043653
Assessing Mental Illness Recovery
An observational study of Serious Mental Illness, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
In 2003 the VA Undersecretary's Action Agenda mandated that mental health services throughout the system be transformed to a recovery model. That mandate and many of the Workgroup recommendations have since been formalized in the Uniform Mental Health Services Package, which specifies a range of recovery-oriented… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Serious Mental Illness
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Sep 2013
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We have elected to focus on individuals meeting accepted criteria for serious mental illness, including a diagnosis of schizophrenia or schizoaffective disorder, bipolar I disorder (with mania), and major depression with psychosis. Individuals meeting these criteria represent a large population with significant costs and health concerns for VA. Further, they are the primary target of efforts to transform mental health care in VA to a recovery model, making this an arena in particular need of a sound recovery instrument. We have elected to limit our sample to people in treatment for several reasons. One can surmise that most people not in treatment are new cases, very ill (e.g., homeless), or doing very well.
Who may be able to join
- chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder I (with mania), or major depression with psychotic features, with a history of a minimum of 2 psychotic exacerbations, or Psychosis NOS
- A minimum of 2 psychotic exacerbations(confirmed by medical record, provider report, or patient self-report);
- Are receiving services from participating study sites and have had a minimum of two service visits within the last 6 months;
- Have received mental health services for a minimum of 3-years;
- Age between 25 and 65;
- Able to provide informed consent; and
- Able to complete protocol assessments (estimation from medical record and/or mental health provider that person can read at 5th grade level and sustain attention to study tasks for required period of time).
Who cannot join
- Severe or profound mental retardation as indicated by chart review
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland, Division of Psychiatry
Baltimore, Maryland, 21201
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20420
About this study
Official title: Assessing Recovery in Veterans With Serious Mental Illness
In 2003 the VA Undersecretary's Action Agenda mandated that mental health services throughout the system be transformed to a recovery model. That mandate and many of the Workgroup recommendations have since been formalized in the Uniform Mental Health Services Package, which specifies a range of recovery-oriented services that must be available to veterans. A key aspect of these policy mandates is the need to assess recovery status of veterans and to monitor their progress over time as a way to evaluate the effectiveness of recovery services. However, there is no established instrument that is suitable for system-wide application. The purpose of this project is to develop a reliable, valid and practical measure of recovery, and use the measure in a study to better understand recovery in individuals with serious mental illness.
Read the detailed description
Mental health care in the United States and Western Europe is undergoing a seismic shift in values. The paternalistic, medical model of care that has dominated practice for more than 75-years is being challenged by an activist group of consumer-survivors, with the support of public officials and an increasing number of professionals. The centerpiece of this shift is the recovery model, which assumes that all consumers have the capacity to improve and develop a life distinct from their illness. The consumer model of recovery involves a non-linear process in which the consumer gradually adapts to, and moves beyond the illness. It emphasizes hope, empowerment, and control of one's life. This model stands in contrast to scientific and clinical models, which view recovery as an outcome, primarily involving reduced symptoms and improved functional capacity.
The public health significance of the consumer perspective is underscored by the President's New Freedom Commission on Mental Health (2003), which enunciated two guiding principles for mental health services in the US: First, services and treatments must be consumer and family centered, geared to give consumers real and meaningful choices about treatment options and providers. Second, care must focus on increasing consumers' ability to successfully cope with life's challenges, on facilitating recovery, and on building resilience, not just managing symptoms. In response to the Commission report the VA has mandated a shift to a recovery model and committed a large amount of resources to implementing it throughout the system.
Despite this political and programmatic change, there is little scientific literature on the nature of recovery or the factors that contribute to it. Systems change is being driven by social mandate and consensual agreement rather than empirical support. It is essential that the consumer model of recovery be subjected to empirical study if it is to have a meaningful and lasting impact on systems and patterns of care. It is also critical to evaluate the recovery-oriented systems of care that have been developed. Two factors that have limited empirical study of the construct and treatment programs are: a) the absence of a scientifically grounded conceptual model of recovery, and b) the lack of a reliable and valid assessment instrument to measure recovery status. The purpose of this project is to develop and evaluate a psychometrically sound assessment scale using Bandura's social cognitive theory as a conceptual model for the recovery construct.
The Specific Aims are: 1) to evaluate and refine the draft version of the Maryland Assessment of Recovery in Serious Mental Illness (MARS), 2) evaluate its test-retest reliability and validity, and 3) to examine recovery status and the relationship of recovery to hypothesized mediators and moderators over a 1-year retest interval.
- Conditions
- Serious Mental Illness
- Keywords
- recovery, serious mental illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maryland Assessment of Recovery in Serious Mental Illness | Individuals with serious mental illness treated in mental health outpatient programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale (PANSS)
The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.
Measured: ~1-year
Secondary outcomes (1)
Maryland Assessment of Recovery in Serious Mental Illness
The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.
Measured: ~ 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionSep 2013
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 Serious Mental IllnessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alan S. Bellack, PhD, Principal investigator, VA Maryland Health Care System, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043653
- Sponsor's protocol ID
- D7156-R
- Acronym
- MARS
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2010
- Last updated
- 8 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Recovery in Veterans With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT01043653
- Acronym / sponsor ID
- MARS / D7156-R
- Conditions
- Serious Mental Illness
- Keywords
- recovery, serious mental illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Posted 10 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2003 the VA Undersecretary's Action Agenda mandated that mental health services throughout the system be transformed to a recovery model. That mandate and many of the Workgroup recommendations have since been formalized in the Uniform Mental Health Services Package, which specifies a range of recovery-oriented services that must be available to veterans. A key aspect of these policy mandates is the need to assess recovery status of veterans and to monitor their progress over time as a way to evaluate the effectiveness of recovery services. However, there is no established instrument that is suitable for system-wide application. The purpose of this project is to develop a reliable, valid and practical measure of recovery, and use the measure in a study to better understand recovery in individuals with serious mental illness.
Detailed description
Mental health care in the United States and Western Europe is undergoing a seismic shift in values. The paternalistic, medical model of care that has dominated practice for more than 75-years is being challenged by an activist group of consumer-survivors, with the support of public officials and an increasing number of professionals. The centerpiece of this shift is the recovery model, which assumes that all consumers have the capacity to improve and develop a life distinct from their illness. The consumer model of recovery involves a non-linear process in which the consumer gradually adapts to, and moves beyond the illness. It emphasizes hope, empowerment, and control of one's life. This model stands in contrast to scientific and clinical models, which view recovery as an outcome, primarily involving reduced symptoms and improved functional capacity.
The public health significance of the consumer perspective is underscored by the President's New Freedom Commission on Mental Health (2003), which enunciated two guiding principles for mental health services in the US: First, services and treatments must be consumer and family centered, geared to give consumers real and meaningful choices about treatment options and providers. Second, care must focus on increasing consumers' ability to successfully cope with life's challenges, on facilitating recovery, and on building resilience, not just managing symptoms. In response to the Commission report the VA has mandated a shift to a recovery model and committed a large amount of resources to implementing it throughout the system.
Despite this political and programmatic change, there is little scientific literature on the nature of recovery or the factors that contribute to it. Systems change is being driven by social mandate and consensual agreement rather than empirical support. It is essential that the consumer model of recovery be subjected to empirical study if it is to have a meaningful and lasting impact on systems and patterns of care. It is also critical to evaluate the recovery-oriented systems of care that have been developed. Two factors that have limited empirical study of the construct and treatment programs are: a) the absence of a scientifically grounded conceptual model of recovery, and b) the lack of a reliable and valid assessment instrument to measure recovery status. The purpose of this project is to develop and evaluate a psychometrically sound assessment scale using Bandura's social cognitive theory as a conceptual model for the recovery construct.
The Specific Aims are: 1) to evaluate and refine the draft version of the Maryland Assessment of Recovery in Serious Mental Illness (MARS), 2) evaluate its test-retest reliability and validity, and 3) to examine recovery status and the relationship of recovery to hypothesized mediators and moderators over a 1-year retest interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maryland Assessment of Recovery in Serious Mental Illness | – | –Individuals with serious mental illness treated in mental health outpatient programs |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We have elected to focus on individuals meeting accepted criteria for serious mental illness, including a diagnosis of schizophrenia or schizoaffective disorder, bipolar I disorder (with mania), and major depression with psychosis. Individuals meeting these criteria represent a large population with significant costs and health concerns for VA. Further, they are the primary target of efforts to transform mental health care in VA to a recovery model, making this an arena in particular need of a sound recovery instrument. We have elected to limit our sample to people in treatment for several reasons. One can surmise that most people not in treatment are new cases, very ill (e.g., homeless), or doing very well.
Key inclusion criteria (7 listed)
- chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder I (with mania), or major depression with psychotic features, with a history of a minimum of 2 psychotic exacerbations, or Psychosis NOS
- A minimum of 2 psychotic exacerbations(confirmed by medical record, provider report, or patient self-report);
- Are receiving services from participating study sites and have had a minimum of two service visits within the last 6 months;
- Have received mental health services for a minimum of 3-years;
- Age between 25 and 65;
Key exclusion criteria (1 listed)
- Severe or profound mental retardation as indicated by chart review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive and Negative Symptom Scale (PANSS)
Time frame: ~1-year
The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.
1 secondary outcome
Maryland Assessment of Recovery in Serious Mental Illness
Time frame: ~ 1-year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Alan S. Bellack, PhD principal investigator
VA Maryland Health Care System, Baltimore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serious Mental Illness, 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 7 inclusion and 1 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 8 Mar 2017. 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 10 Jan 2017). 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?
Positive and Negative Symptom Scale (PANSS) (time frame: ~1-year). 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 8 Mar 2017.