Illness Management and Recovery for Veterans With Severe Mental Illness

Not Applicable

Completed

• Conditions: Schizophrenia; Schizo-affective Disorder

• Registration Number: NCT00515671
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2007-08-10
• Study First Submitted QC: 2007-08-10
• Study First Posted: 2007-08-14
• Study Start: 2008-01
• Primary Completion: 2012-04
• Study Completion: 2013-09
• Results First Submitted: 2014-10-03
• Results First Submitted QC: 2014-10-08
• Results First Posted: 2014-10-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 (MCMHC) 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Illness Management Ratings	Baseline, 9 months, 18 months	Illness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.

Secondary Outcome Measures

Name	Time	Method
Psychiatric Symptoms (PANSS Total)	Baseline, 9 months, 18 months	Psychiatric symptomatology was assessed by the Positive and Negative Syndrome Scale (PANSS), a widely-used, 30-item rating scale. The PANSS has previously demonstrated satisfactory internal consistency, test-retest reliability, and validity. Raters were trained to reach inter-rater agreement of .80 prior to interviewing participants. This is the total score, which ranges from 30 to 210, with higher scores indicating more severe symptoms.

Trial Locations

Locations (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN; 🇺🇸 Indianapolis, Indiana, United States