- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043653
Assessing Mental Illness Recovery (MARS)
Assessing Recovery in Veterans With Serious Mental Illness
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20420
- Washington DC VA Medical Center
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Maryland
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Baltimore, Maryland, United States, 21201
- VA Maryland Health Care System, Baltimore
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Baltimore, Maryland, United States, 21201
- University of Maryland, Division of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Severe or profound mental retardation as indicated by chart review
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Maryland Assessment of Recovery in Serious Mental Illness
Individuals with serious mental illness treated in mental health outpatient programs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Positive and Negative Symptom Scale (PANSS)
Time Frame: ~1-year
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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.
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~1-year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maryland Assessment of Recovery in Serious Mental Illness
Time Frame: ~ 1-year
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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.
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~ 1-year
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Collaborators and Investigators
Investigators
- Principal Investigator: Alan S. Bellack, PhD, VA Maryland Health Care System, Baltimore
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D7156-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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