search
Back to results

Illness Management and Recovery for Veterans With Severe Mental Illness

Primary Purpose

Schizophrenia, Schizo-affective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Illness Management and Recovery
Problem Solving
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring self-management, recovery, severe mental illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1_IMR

Arm 2_PS

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Illness Management Ratings
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

Psychiatric Symptoms (PANSS Total)
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.

Full Information

First Posted
August 10, 2007
Last Updated
December 7, 2021
Sponsor
VA Office of Research and Development
Collaborators
Indiana University, Dartmouth College
search

1. Study Identification

Unique Protocol Identification Number
NCT00515671
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Indiana University, Dartmouth College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo-affective Disorder
Keywords
self-management, recovery, severe mental illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1_IMR
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 2_PS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Illness Management and Recovery
Other Intervention Name(s)
IMR
Intervention Description
a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
Intervention Type
Behavioral
Intervention Name(s)
Problem Solving
Other Intervention Name(s)
PS
Intervention Description
Weekly problem-solving support group
Primary Outcome Measure Information:
Title
Illness Management Ratings
Description
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.
Time Frame
Baseline, 9 months, 18 months
Secondary Outcome Measure Information:
Title
Psychiatric Symptoms (PANSS Total)
Description
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.
Time Frame
Baseline, 9 months, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle P Salyers, MS PhD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23815174
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.
Results Reference
result
PubMed Identifier
24011850
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.
Results Reference
result
PubMed Identifier
23410979
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.
Results Reference
result
PubMed Identifier
24178191
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.
Results Reference
result
PubMed Identifier
24733680
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.
Results Reference
result
PubMed Identifier
22854724
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.
Results Reference
result
PubMed Identifier
21208857
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.
Results Reference
result

Learn more about this trial

Illness Management and Recovery for Veterans With Severe Mental Illness

We'll reach out to this number within 24 hrs