Clinical trial NCT01043653: Assessing Mental Illness Recovery
Official title: Assessing Recovery in Veterans With Serious Mental Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serious Mental Illness
Keywords: recovery
serious mental illness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-01-07
Enrollment: 250
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive and Negative Symptom Scale (PANSS)
timeFrame: ~1-year
Secondary outcomes:
measure: Maryland Assessment of Recovery in Serious Mental Illness
timeFrame: ~ 1-year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: University of Maryland, Division of Psychiatry
state: Maryland
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
Study officials:
affiliation: VA Maryland Health Care System, Baltimore
name: Alan S. Bellack, PhD
role: PRINCIPAL_INVESTIGATOR
References: