Assessing Recovery (MARS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01043653
First received: January 5, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 veterans with serious mental illness.


Condition
Serious Mental Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Recovery in Veterans With Serious Mental Illness

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Positive and Negative Symptom Scale (PANSS) [ Time Frame: 1-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maryland Assessment of Recovery in Serious Mental Illness [ Time Frame: 1-year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

no specimens collected


Estimated Enrollment: 200
Study Start Date: January 2010
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
200 veterans with serious mental illness treated in VA mental health outpatient programs

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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. Veterans 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.

Criteria

Inclusion Criteria:

  • SCID diagnoses 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043653

Locations
United States, District of Columbia
VA Central Office - HSR&D
Washington, District of Columbia, United States, 20420
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Alan S. Bellack, PhD VA Maryland Health Care System, Baltimore
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01043653     History of Changes
Other Study ID Numbers: D7156-R
Study First Received: January 5, 2010
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
recovery
serious mental illness

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014