Assessing Mental Illness Recovery

NCT01043653 | Completed Results

• 1 other identifier: D7156-R
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

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.

Conditions

Serious Mental Illness

Keywords

recovery; serious mental illness

Outcome Measures

Primary Outcomes (1)

• 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.

  ~1-year

Secondary Outcomes (1)

• Maryland Assessment of Recovery in Serious Mental Illness

  ~ 1-year

Study Arms (1)

Maryland Assessment of Recovery in Serious Mental Illness

Individuals with serious mental illness treated in mental health outpatient programs

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Severe or profound mental retardation as indicated by chart review

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20420, United States

Location

University of Maryland, Division of Psychiatry

Baltimore, Maryland, 21201, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: NONE RETAINED

no specimens collected

Results Point of Contact

• Title: Dr. Amy Drapalski
• Organization: VISN 5 MIRECC

amy.drapalski@va.gov

410-637-1855

Study Officials

• Alan S. Bellack, PhD

  VA Maryland Health Care System, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 8, 2017
• Results First Posted: January 10, 2017

Record last verified: 2017-01

Locations

US (3)