Schizo-affective Disorder, Schizophrenia
Conditions
Keywords
self-management, recovery, severe mental illness
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.
Interventions
BEHAVIORALIllness Management and Recovery
a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
BEHAVIORALProblem Solving
Weekly problem-solving support group
Sponsors
Indiana University
Dartmouth College
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Receives IMR groups once a week for 9 months in addition to care as usual.
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 | 60 |
| Arm 2 Receives support groups once a week for 9 months in addition to care as usual.
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 | 58 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | incarcerated | 1 | 2 |
| Overall Study | Lost to Follow-up | 13 | 10 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Arm 2 | Arm 1 | Total |
|---|---|---|---|
| Age, Continuous | 47.6 years STANDARD_DEVIATION 8.5 | 47.7 years STANDARD_DEVIATION 9.3 | 47.7 years STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized African American | 40 participants | 32 participants | 72 participants |
| Race/Ethnicity, Customized More than one | 0 participants | 6 participants | 6 participants |
| Race/Ethnicity, Customized white | 18 participants | 22 participants | 40 participants |
| Region of Enrollment United States | 58 participants | 60 participants | 118 participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 48 Participants | 46 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 58 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 |
Outcome results
Primary
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.
Time frame: Baseline, 9 months, 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Illness Management Ratings | Illness Management-baseline | 3.5 units on a scale | Standard Deviation 0.5 |
| Arm 1 | Illness Management Ratings | Illness Management-9 months | 3.5 units on a scale | Standard Deviation 0.6 |
| Arm 1 | Illness Management Ratings | Illness Management - 18 months | 3.6 units on a scale | Standard Deviation 0.5 |
| Arm 2 | Illness Management Ratings | Illness Management-baseline | 3.3 units on a scale | Standard Deviation 0.5 |
| Arm 2 | Illness Management Ratings | Illness Management-9 months | 3.6 units on a scale | Standard Deviation 0.6 |
| Arm 2 | Illness Management Ratings | Illness Management - 18 months | 3.5 units on a scale | Standard Deviation 0.6 |
p-value: 0.8868Mixed Models Analysis
Secondary
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.
Time frame: Baseline, 9 months, 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Psychiatric Symptoms (PANSS Total) | Total Symptoms - Baseline | 75.1 units on a scale | Standard Deviation 16.1 |
| Arm 1 | Psychiatric Symptoms (PANSS Total) | Total Symptoms - 9 months | 68.5 units on a scale | Standard Deviation 18.5 |
| Arm 1 | Psychiatric Symptoms (PANSS Total) | Total Symptoms - 18 months | 61.9 units on a scale | Standard Deviation 17.1 |
| Arm 2 | Psychiatric Symptoms (PANSS Total) | Total Symptoms - Baseline | 76.1 units on a scale | Standard Deviation 15.3 |
| Arm 2 | Psychiatric Symptoms (PANSS Total) | Total Symptoms - 9 months | 66.6 units on a scale | Standard Deviation 14.9 |
| Arm 2 | Psychiatric Symptoms (PANSS Total) | Total Symptoms - 18 months | 65.3 units on a scale | Standard Deviation 19.6 |
p-value: 0.3328Mixed Models Analysis