- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00515671
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1_IMR
Illness Management and Recovery was offered in small groups (less than 8), co-facilitated by either an experienced masters level clinician or a doctoral level psychologist and by a doctoral student in clinical psychology.
Facilitators used the IMR curriculum, incorporating psychoeducation, cognitive-behavioral approaches, relapse prevention, social skills training, and coping skills training.
Facilitators worked with groups to set personal recovery goals and address progress towards those goals throughout the intervention.
Home assignments helped participants apply newly learned skills and/or make progress on goals.
Groups were open to rolling admission across the study period
|
a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
Other Names:
|
Placebo Comparator: Arm 2_PS
Problem Solving was the active control condition (also offered in groups weekly for 9 months).
Participants were encouraged to discuss current concerns and receive group support; we did not use structured problem solving tasks.
These groups were led by the same facilitators described above, who helped establish group expectations (attendance, confidentiality), encouraged participation, and provided process-oriented observations; there was no formal curriculum, goal setting, or homework assignments.
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Weekly problem-solving support group
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illness Management Ratings
Time Frame: 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.
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Baseline, 9 months, 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychiatric Symptoms (PANSS Total)
Time Frame: 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.
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Baseline, 9 months, 18 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Michelle P Salyers, MS PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IAC 05-254
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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