Clinical trial NCT00515671: Illness Management and Recovery for Veterans With Severe Mental Illness
Official title: Illness Management and Recovery for Veterans With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo-affective Disorder
Keywords: self-management
recovery
severe mental illness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Indiana University
name: Dartmouth College
First posted: 2007-08-14
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 (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

Primary outcomes:
measure: Illness Management Ratings
timeFrame: Baseline, 9 months, 18 months
Secondary outcomes:
measure: Psychiatric Symptoms (PANSS Total)
timeFrame: Baseline, 9 months, 18 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Michelle P Salyers, MS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frankel RM, Salyers MP, Bonfils KA, Oles SK, Matthias MS. Agenda setting in psychiatric consultations: an exploratory study. Psychiatr Rehabil J. 2013 Sep;36(3):195-201. doi: 10.1037/prj0000004. Epub 2013 Jul 1.
citation: McGuire AB, Bonfils KA, Kukla M, Myers L, Salyers MP. Measuring participation in an evidence-based practice: illness management and recovery group attendance. Psychiatry Res. 2013 Dec 30;210(3):684-9. doi: 10.1016/j.psychres.2013.08.008. Epub 2013 Sep 5.
citation: Matthias MS, Salyers MP, Frankel RM. Re-thinking shared decision-making: context matters. Patient Educ Couns. 2013 May;91(2):176-9. doi: 10.1016/j.pec.2013.01.006. Epub 2013 Feb 11.
citation: McGuire AB, Kukla M, Green A, Gilbride D, Mueser KT, Salyers MP. Illness management and recovery: a review of the literature. Psychiatr Serv. 2014 Feb 1;65(2):171-9. doi: 10.1176/appi.ps.201200274.
citation: Salyers MP, McGuire AB, Kukla M, Fukui S, Lysaker PH, Mueser KT. A randomized controlled trial of illness management and recovery with an active control group. Psychiatr Serv. 2014 Aug 1;65(8):1005-11. doi: 10.1176/appi.ps.201300354.
citation: McGuire AB, Stull LG, Mueser KT, Santos M, Mook A, Rose N, Tunze C, White LM, Salyers MP. Development and reliability of a measure of clinician competence in providing illness management and recovery. Psychiatr Serv. 2012 Aug;63(8):772-8. doi: 10.1176/appi.ps.201100144.
citation: Tsai J, Salyers MP, McGuire AB. A cross-sectional study of recovery training and staff attitudes in four community mental health centers. Psychiatr Rehabil J. 2011 Winter;34(3):186-93. doi: 10.2975/34.3.2011.186.193.