Severe Mental Illness
Conditions
Brief summary
Illness Management and Recovery (IMR) is an evidenced-based approach to teaching consumers with severe mental illness how to set and achieve personal recovery goals and acquire the knowledge and skills to independently manage their illnesses. Longitudinal, multi-site, and randomized controlled trials have shown IMR to be effective in increasing illness self-management and coping; some evidence also points to reduced hospitalization rates. Fidelity, or adherence to a specific treatment model, is equally important to both clinical research and to the practical dissemination of evidence-based practices to the field. To this end, the research team has developed an IMR clinician-level fidelity assessment, the IMR Treatment Integrity Scale (IT-IS). However, the validity of the preliminary IT-IS has not been rigorously evaluated. Additionally, it is crucial to develop strategies to utilize the IT IS to increase adherence to the IMR model and ultimately increase consumer outcomes. The purpose of this study is to assess the construct validity of the IT-IS by testing the relationship between IT-IS elements and mechanisms of change and proximal outcomes. The investigators will collect a sample of IMR session recordings and pre-post data from IMR participants from recruitment sites in Indiana, New Jersey and several other states. The investigators will test hypothesized relationships between specific program elements and theoretically proposed mechanisms of change. The investigators will also assess organizational and clinician factors affecting IMR competence by including a survey for the staff members who are located as sites where the investigators have clinicians participating in providing IMR.
Interventions
None listed
Sponsors
Indiana University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinicians: * 18 years or older * Providing IMR individually or in group format at a participating agency * Willing and able to provide consent * Willing to complete study measures * Willing to be audio recorded Consumers: * 18 years or older * Willing and able to provide consent * Able to complete a brief cognitive screener * Willing to complete study measures * Receiving IMR intervention at a participating agency * Willing to be audio recorded
Exclusion criteria
* Individuals younger than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Illness Management and Recovery Scale | 3-Months | Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale. |
| Illness Management and Recovery Treatment Integrity Scale | 3-Months | Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adult State Hope Scale | 3-Months | This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being Definitely False and 4 being Definitely True). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample. |
| Brief COPE Adaptive Subscale | 3-Months | This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies). |
| Working Alliance Inventory Short Form | 3-Months | This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score. |
| UNCOPE Measure | 3-Months | This meThis measure is a consumer rated substance abuse screener consisting of 6 yes or no questions. A response of yes is assigned a value of 1. The total number of yes responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues). |
| Brief COPE Maladaptive Subscale | 3-Months | This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies). |
| Medication Adherence Rating Scale | 3-Months | This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as yes or no. A yes is assigned a value of 1. The scale ranges from 0 (no yes responses) to 10 (all yes responses endorsed). The total number of yes responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence. |
| Multidimensional Scale of Perceived Social Support | 3-Months | This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IMR Consumers Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention. | 236 |
| IMR Clinicians Clinicians who provided the IMR intervention to the IMR Consumers | 62 |
| Total | 298 |
Baseline characteristics
| Characteristic | IMR Consumers | Total | IMR Clinicians |
|---|---|---|---|
| Adult State Hope Scale | 18.8 units on a scale STANDARD_DEVIATION 3.7 | 18.8 units on a scale STANDARD_DEVIATION 3.7 | NA units on a scale |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 231 Participants | 292 Participants | 61 Participants |
| Brief COPE Inventory Adaptive Coping Subscale | 5.64 units on a scale STANDARD_DEVIATION 1.4 | 5.64 units on a scale STANDARD_DEVIATION 1.4 | NA units on a scale |
| Brief COPE Inventory Maladaptive Coping Subscale | 4.46 units on a scale STANDARD_DEVIATION 1.2 | 4.46 units on a scale STANDARD_DEVIATION 1.2 | NA units on a scale |
| Gender Female | 90 participants | 131 participants | 41 participants |
| Gender Male | 128 participants | 149 participants | 21 participants |
| Illness Management and Recovery Scale | 3.55 units on a scale STANDARD_DEVIATION 0.6 | 3.55 units on a scale STANDARD_DEVIATION 0.6 | NA units on a scale |
| Medication Adherence Rating Scale | 2.45 units on a scale STANDARD_DEVIATION 0.12 | 2.45 units on a scale STANDARD_DEVIATION 0.12 | NA units on a scale |
| Multidimensional Scale of Perceived Social Support | 4.94 units on a scale STANDARD_DEVIATION 1.7 | 4.94 units on a scale STANDARD_DEVIATION 1.7 | NA units on a scale |
| Region of Enrollment United States | 236 participants | 298 participants | 62 participants |
| UNCOPE | 1.88 units on a scale STANDARD_DEVIATION 0.13 | 1.88 units on a scale STANDARD_DEVIATION 0.13 | NA units on a scale |
| Working Alliance Inventory Short Form | 5.65 units on a scale STANDARD_DEVIATION 1 | 5.65 units on a scale STANDARD_DEVIATION 1 | NA units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 236 | 0 / 63 |
| serious Total, serious adverse events | 0 / 236 | 0 / 63 |
Outcome results
Primary
Illness Management and Recovery Scale
Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Illness Management and Recovery Scale | 3.72 units on a scale | Standard Deviation 0.5 |
p-value: <0.01t-test, 2 sided
Primary
Illness Management and Recovery Treatment Integrity Scale
Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR.
Time frame: 3-Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Illness Management and Recovery Treatment Integrity Scale | 2.73 units on a scale | Standard Deviation 0.55 |
Comparison: Hypothesized that higher levels of IMR competence would predict higher IMRS outcomes.p-value: <0.05Regression, Linear
Secondary
Adult State Hope Scale
This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being Definitely False and 4 being Definitely True). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample.
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Adult State Hope Scale | 19.13 units on a scale | Standard Deviation 3.6 |
Secondary
Brief COPE Adaptive Subscale
This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies).
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Brief COPE Adaptive Subscale | 5.73 units on a scale | Standard Deviation 1.3 |
Secondary
Brief COPE Maladaptive Subscale
This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies).
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Brief COPE Maladaptive Subscale | 4.47 units on a scale | Standard Deviation 1.1 |
Secondary
Medication Adherence Rating Scale
This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as yes or no. A yes is assigned a value of 1. The scale ranges from 0 (no yes responses) to 10 (all yes responses endorsed). The total number of yes responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence.
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Medication Adherence Rating Scale | 2.45 units on a scale | Standard Deviation 0.15 |
Secondary
Multidimensional Scale of Perceived Social Support
This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support).
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Multidimensional Scale of Perceived Social Support | 5.18 units on a scale | Standard Deviation 0.11 |
Secondary
UNCOPE Measure
This meThis measure is a consumer rated substance abuse screener consisting of 6 yes or no questions. A response of yes is assigned a value of 1. The total number of yes responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues).
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | UNCOPE Measure | .30 units on a scale | Standard Deviation 0.03 |
Secondary
Working Alliance Inventory Short Form
This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score.
Time frame: 3-Months
Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IMR Consumers | Working Alliance Inventory Short Form | 5.58 units on a scale | Standard Deviation 1 |