Illness Management and Recovery for Veterans With Severe Mental Illness

This study is ongoing, but not recruiting participants.
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: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Schizophrenia
Schizo-affective Disorder
Behavioral: Illness Management and Recovery Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Illness Management and Recovery for Veterans With Severe Mental Illness

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Illness Management Ratings, Patient Activation, Functioning Level, Perceived Recovery [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychiatric symptoms, substance abuse, hope, employment, independent living [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: January 2008
Estimated Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Receives IMR groups once a week for 9 months in addition to care as usual.
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
Placebo Comparator: Arm 2
Receives support groups once a week for 9 months in addition to care as usual.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515671

Locations
United States, Indiana
Richard Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Indiana University
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Michelle P Salyers, MS PhD Richard Roudebush VA Medical Center, Indianapolis
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00515671     History of Changes
Other Study ID Numbers: IAC 05-254
Study First Received: August 10, 2007
Last Updated: September 17, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
self-management
recovery
severe mental illness

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 17, 2012