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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-Months |
| 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. | 3-Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-Months |
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Inclusion Criteria:
Clinicians:
Consumers:
Exclusion Criteria:
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Consumers with mental illness, who are participating in the Illness Management and Recovery intervention in New Jersey and Indiana. This includes consumers from state hospitals, rehabilitation centers and community mental health centers. Additionally, the clinicians who are leading the intervention are considered to be participants of the study as well.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMR Consumers | Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention. |
| FG001 | IMR Clinicians | The clinicians who provided IMR intervention to the IMR Consumers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One clinician did not complete the baseline measures, thus leaving us the baseline characteristics for 62 IMR Clinicians. The only baseline measure collected for the IMR Clinicians were demographic variables (i.e. Age, Gender, Region of Employment). The remaining outcome measures aren't collected because they are specific to the patient population.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMR Consumers | Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention. |
| BG001 | IMR Clinicians | Clinicians who provided the IMR intervention to the IMR Consumers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Every attempt was made to collect this information from all participants, however this data was missing in some instances. Data was collected via self-report, and thus if the question was omitted by the participant the data was not available for analyses. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
|
Data was collected for 3-months during the study intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMR Consumers | Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention. |
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Unable to randomly assign a level of competency in providing IMR. Geographically limited to three states within the United States. Relatively brief observation period (3-months).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alan B. McGuire | Indiana University Purdue University Indianapolis | 3179882725 | abmcguir@iupui.edu |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 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). |
| 3-Months |
| 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. | 3-Months |
| 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). | 3-Months |
| 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. | 3-Months |
| 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). | 3-Months |
| 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). | 3-Months |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Gender | Every attempt was made to collect this information from all participants, however this data was missing in some instances. Data was collected via self-report, and thus if the question was omitted by the participant the data was not available for analyses. | Number | participants |
|
| Region of Enrollment | Every attempt was made to collect this information from all participants, however this data was missing in some instances. Data was collected via self-report, and thus if the question was omitted by the participant the data was not available for analyses. | Number | participants |
|
| Illness Management and Recovery Scale | 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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). | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| UNCOPE | This 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). | Mean | Standard Deviation | units on a scale |
|
| Brief COPE Inventory Adaptive Coping 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). | Mean | Standard Deviation | units on a scale |
|
| Brief COPE Inventory Maladaptive Coping 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). | Mean | Standard Deviation | units on a scale |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
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| 0 |
| 236 |
| 0 |
| 236 |
| EG001 | IMR Clinicians | Clinician participants who are providing Illness Management and Recovery (IMR) intervention. | 0 | 63 | 0 | 63 |
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