Illness Management and Recovery for Veterans With Severe Mental Illness

This study has been completed.
Sponsor:
Collaborators:
Indiana University
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00515671
First received: August 10, 2007
Last updated: April 18, 2014
Last verified: April 2014

August 10, 2007
April 18, 2014
January 2008
April 2012   (final data collection date for primary outcome measure)
Illness Management Ratings, Patient Activation, Functioning Level, Perceived Recovery [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Illness Management Ratings, Patient Activation, Functioning Level, Perceived Recovery [ Time Frame: 18 months ]
Complete list of historical versions of study NCT00515671 on ClinicalTrials.gov Archive Site
Psychiatric symptoms, substance abuse, hope, employment, independent living [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Psychiatric symptoms, substance abuse, hope, employment, independnet living [ Time Frame: 18 months ]
Not Provided
Not Provided
 
Illness Management and Recovery for Veterans With Severe Mental Illness
Illness Management and Recovery for Veterans With Severe Mental Illness

The President's New Freedom Commission on Mental Health has called for a transformation of the mental health system to partner with consumers of those services in delivering effective interventions focused on recovery, and the Department of Veterans Affairs (VA) has developed a Mental Health Strategic Plan to address these recommendations. One promising approach is to implement Illness Management and Recovery (IMR), a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness.

IMR was developed from a review of effective approaches for illness self-management training in persons with severe mental illness. The 9-month curriculum is taught using motivational, educational, and cognitive-behavioral techniques, and incorporates five evidence-based practices: education about mental illness, strategies for increasing medication adherence, skills training to enhance social support, relapse prevention planning, and coping skills training. The program was developed for widespread dissemination and includes a manual, worksheets, an introductory video, a clinical training video, a fidelity scale, and informational brochures for consumers, family members, clinicians, and administrators.

Background:

The President's New Freedom Commission on Mental Health has called for a transformation of the mental health system to partner with consumers of those services in delivering effective interventions focused on recovery, and the Department of Veterans Affairs (VA) has developed aMental Health Strategic Plan to address these recommendations. One promising approach is to implement Illness Management and Recovery (IMR), a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness.

IMR was developed from a review of effective approaches for illness self-management training in persons with severe mental illness. The 9-month curriculum is taught using educational, motivational, and cognitive-behavioral techniques, and incorporates five evidence-based practices: education about mental illness, strategies for increasing medication adherence, skills training to enhance social support, relapse prevention planning, and coping skills training. The program was developed for widespread dissemination and includes a manual, worksheets, an introductory video, a clinical training video, a fidelity scale, and informational brochures for consumers, family members, clinicians, and administrators.

Objective:

Although IMR is based on practices shown to be effective in controlled research, effectiveness of the comprehensive package of IMR has not yet been demonstrated in a randomized, controlled trial. The primary aim of the proposed research is to test the effectiveness of IMR as an implementation package. Our primary focus is to examine the impact of IMR intervention on consumer outcomes related to illness self-management and recovery.

Methods:

This is a randomized, controlled trial comparing IMR to usual mental health treatment, with an attention-control group in 200 veterans with schizophrenia spectrum disorders. Assessment will include semi-structured interviews and standardized measures at baseline, 9 months, and 18 months to assess illness self-management (e.g., symptoms), objective indicators of recovery (e.g., role functioning), and subjective indicators of recovery (e.g., perceptions of well-being). Electronic medical records will be accessed to determine the impact of IMR on other service utilization and costs.

Impact:

The proposed study directly addresses a stated need in the VA's Mental Health Strategic Plan and is a critical first step to systematically evaluating the effectiveness of a comprehensive, manual-based approach to improving recovery outcomes for veterans with severe mental illness. As an implementation package, IMR offers mental health providers useful tools that could be widely disseminated across the VA system.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Schizo-affective Disorder
Behavioral: Illness Management and Recovery Training
a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
Other Name: Experimental group is the IMR training program; the Control group is a weekly support group
  • Experimental: Arm 1
    Receives IMR groups once a week for 9 months in addition to care as usual.
    Intervention: Behavioral: Illness Management and Recovery Training
  • Placebo Comparator: Arm 2
    Receives support groups once a week for 9 months in addition to care as usual.
    Intervention: Behavioral: Illness Management and Recovery Training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
September 2013
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently receiving (or newly admitted to) mental health services from any mental health treatment programs at the Roudebush VAMC or Midtown Community Mental Health Center in Indianapolis, IN
  • Age 18 or older
  • SCID-confirmed diagnosis of schizophrenia or schizoaffective disorder
  • Stated interest in learning more about their illness
  • Willing and able to give informed consent

Exclusion Criteria:

  • Severe medical condition that would limit participation in an 18-month study (e.g., end stage renal disease, metastatic cancer, life expectancy less than 18 months; if participant is unsure, with permission will contact primary physician)
  • Evidence of dementia or severe cognitive dysfunction on cognitive screener
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00515671
IAC 05-254
No
Department of Veterans Affairs
Department of Veterans Affairs
  • Indiana University
  • Dartmouth-Hitchcock Medical Center
Principal Investigator: Michelle P Salyers, MS PhD Richard Roudebush VA Medical Center, Indianapolis
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP