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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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For this project we propose to refine the psychosocial intervention developed in phase one, based on input from key stakeholders, and to test the feasibility, acceptability and preliminary efficacy of the intervention. The proposed project addresses unmet public health needs for a historically hard-to-reach group of individuals with epilepsy and comorbid serious mental illnesses, and as the intervention is an adjunct to care that individuals with serious mental illness are already receiving, and uses staff already likely to be present in a care system, it is ideally suited for "real-world" implementation in people with epilepsy and serious mental illness (E-SMI).
The purpose of this study is to try and engage individuals with E-SMI to actively participate in illness self-management and treatment adherence that are crucial in minimizing the morbidity and mortality associated with both chronic mental disorders and chronic neurological conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIME | Experimental | This arm will receive the TIME intervention. |
|
| Treatment as Usual (TAU) | No Intervention | This arm will receive treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIME | Behavioral | TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) | The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Disability Assessment (WHODAS II) | The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assess functioning and disabilities in activities of daily living, including mobility, self-care, and life activities. Sum Scores from 32-180 with higher scores indicating greater degree of disability. | Baseline, 12 Week, 16 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
14 participants were excluded at Screening because they did not meet the inclusion criteria: 4 No SMI, 2 No epilepsy, 3 No show (unwilling to participate), 3 withdrew from study, 1 Single episode SMI,1 Pregnancy
We used the electronic medical record from a large citywide healthcare system to preliminarily identify people with an epilepsy diagnosis and invited them to participate in the RCT.
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| ID | Title | Description |
|---|---|---|
| FG000 | TIME | This arm will receive the TIME intervention. TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews. |
| FG001 | Treatment as Usual (TAU) | This arm will receive treatment as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Week 12 (3 Months) |
| |||||||||||||
| Week 16 (4 Months) |
|
Individuals with epilepsy and comorbid mental illness.
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| ID | Title | Description |
|---|---|---|
| BG000 | TIME | This arm will receive the TIME intervention. TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Montgomery Asberg Depression Rating Scale (MADRS) | The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression. | Individuals with epilepsy and comorbid mental illness. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 16 |
|
All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.
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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 | TIME | This arm will receive the TIME intervention. TIME: TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgeries | Surgical and medical procedures | Non-systematic Assessment | Outpatient surgery for the arm. |
Limitations included small sample size & a single-site setting which may not be representative of people with E-MI. Those who agree to participate in a clinical trial may be more help-seeking than individuals with E-MI more broadly. We excluded individuals too psychiatrically ill to participate in groups. Additionally, raters were not blind to randomization assignment, we did not collect information on psychotropic medication changes or adherence, & epilepsy diagnosis was not verified with EEG.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy Yala, Data & Regulatory Coordinator II | Case Western Reserve University | 216-368-0783 | jxy790@case.edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| ID | Term |
|---|---|
| D013995 | Time |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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|
| Quality of Life Questionnaire (QOLIE-10) | The QOLIE-10-P is a self-administered questionnaire and comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The sum score is used in the analysis. Scores from 1-5 with lower scores indicating the least amount of problems | Baseline, 12 Week, 16 Week |
| Patient Health Questionnaire (PHQ-9) | Scores from 0-27 with higher scores indicating more severe depressive symptoms. | Baseline, 12 Week, 16 Week |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI contains 19 self-rated questions that are combined to form seven "component" scores each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21, "0" indicating no difficulty and "21" indicating severe difficulties in all areas (with higher scores indicating worse sleep quality). | Baseline, 12 Week, 16 Week |
| Brief Psychiatric Rating Scale (BPRS) | The BPRS is a tool clinicians or researchers use to measure psychiatric symptoms such as anxiety, depression, and psychoses. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. The total Score is the sum of all 18-items. Score ranges from 18-126 with higher scores indicating more psychiatric symptoms. | Baseline, 12 Week, 16 Week |
| Global Assessment of Functioning (GAF) | The GAF assesses psychological, social and occupational functioning on a hypothetical continuum of mental health illness. Scores range from 0-100 with higher scores indicating higher global functioning. | Baseline, 12 Week, 16 Week |
| Seizure Frequency - Past 30 Days | Self reported seizure frequency in the past 30 days | Baseline, 12 Week, 16 Week |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Treatment as Usual (TAU) | This arm will receive treatment as usual. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Living Situation | Count of Participants | Participants |
|
| Income Level | Count of Participants | Participants |
|
| Seizure Type | Number | seizures |
|
| Mental Health Diagnosis | Count of Participants | Participants |
|
| Duration of Mental Health Disorder (in years) | Mean | Standard Deviation | years |
|
| Duration of Epilepsy (in years) | Mean | Standard Deviation | years |
|
| Charlson Comorbidity Index (CCI) | Self-reported Charlson Comorbidity Index (CCI) is comprised of the presence of 10 medical conditions including respiratory diseases, rheumatological diseases, cancer, diabetes, digestive problems, heart trouble, HIV/ AIDS, kidney disease, liver disease, & stroke. Total Score is the sum of all 10-items, each item checked gets 1 point, except heart disease & kidney disease which get 2 points each, liver disease gets 3 points, and cancer & HIV/AIDS which get 6 points each. The CCI summary score range from 0-24. A higher score is associated with increased risk of mortality. | Mean | Standard Deviation | scores on a scale |
|
| Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) | The Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) is an 11 item measure that identifies patients that are at high risk for having limited health literacy and identifies the grade level of the patient if they read below the ninth grade level. Each correctly pronounced word gets 1 point. The REALM-R Total Score is the sum of correct word pronunciations. With a total score ranging from 0 to 11. A score of 6 or less indicates risk for poor health literacy. | Mean | Standard Deviation | scores on a scale |
|
| Treatment as Usual (TAU) |
This arm will receive treatment as usual. |
|
|
|
| Secondary | World Health Organization Disability Assessment (WHODAS II) | The World Health Organization Disability Assessment Schedule (WHODAS 2.0) assess functioning and disabilities in activities of daily living, including mobility, self-care, and life activities. Sum Scores from 32-180 with higher scores indicating greater degree of disability. | Individuals with epilepsy and comorbid mental illness with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 Week, 16 Week |
|
|
|
|
| Secondary | Quality of Life Questionnaire (QOLIE-10) | The QOLIE-10-P is a self-administered questionnaire and comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The sum score is used in the analysis. Scores from 1-5 with lower scores indicating the least amount of problems | Individuals with epilepsy and comorbid mental illness with available data. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12 Week, 16 Week |
|
|
|
|
| Secondary | Patient Health Questionnaire (PHQ-9) | Scores from 0-27 with higher scores indicating more severe depressive symptoms. | Individuals with epilepsy and comorbid mental illness with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 Week, 16 Week |
|
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | The PSQI contains 19 self-rated questions that are combined to form seven "component" scores each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21, "0" indicating no difficulty and "21" indicating severe difficulties in all areas (with higher scores indicating worse sleep quality). | Individuals with epilepsy and comorbid mental illness with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 Week, 16 Week |
|
|
|
|
| Secondary | Brief Psychiatric Rating Scale (BPRS) | The BPRS is a tool clinicians or researchers use to measure psychiatric symptoms such as anxiety, depression, and psychoses. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. The total Score is the sum of all 18-items. Score ranges from 18-126 with higher scores indicating more psychiatric symptoms. | Individuals with epilepsy and comorbid mental illness with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 Week, 16 Week |
|
|
|
|
| Secondary | Global Assessment of Functioning (GAF) | The GAF assesses psychological, social and occupational functioning on a hypothetical continuum of mental health illness. Scores range from 0-100 with higher scores indicating higher global functioning. | Individuals with epilepsy and comorbid mental illness with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 Week, 16 Week |
|
|
|
|
| Secondary | Seizure Frequency - Past 30 Days | Self reported seizure frequency in the past 30 days | Individuals with epilepsy and comorbid mental illness with available data. | Posted | Mean | Standard Deviation | number of seizures | Baseline, 12 Week, 16 Week |
|
|
|
|
| 0 |
| 22 |
| 12 |
| 22 |
| 2 |
| 22 |
| EG001 | Treatment as Usual (TAU) | This arm will receive treatment as usual. | 0 | 22 | 1 | 22 | 0 | 22 |
| Seizures | Nervous system disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment | Low blood pressure |
|
| Heart condition | Cardiac disorders | Non-systematic Assessment |
|
| Blood Sugar | Blood and lymphatic system disorders | Non-systematic Assessment | elevated blood sugar |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mini Stroke | Cardiac disorders | Systematic Assessment |
|
| Limb amputation | Injury, poisoning and procedural complications | Non-systematic Assessment | leg amputated due to complications of vascular surgery. |
|
| Circulatory Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
|
| Foot issue | General disorders | Non-systematic Assessment | Swollen and painful foot, treated and released. |
|
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| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| 12 week |
|
|
| 16 week |
|
|
| t-test, 2 sided |
| 0.204 |
| Other |
| 12 Week |
|
|
| 16 Week |
|
|
| t-test, 2 sided |
| 0.978 |
| Other |
| 12 Week |
|
|
| 16 Week |
|
|
| t-test, 2 sided |
| 0.015 |
| Other |
| 12 Week |
|
|
| 16 Week |
|
|
| t-test, 2 sided |
| 0.471 |
| Other |
| 12 Week |
|
|
| 16 Week |
|
|
| t-test, 2 sided |
| 0.433 |
| Other |
| 12 Week |
|
|
| 16 Week |
|
|
| t-test, 2 sided |
| 0.600 |
| Other |
| 12 Week |
|
|
| 16 Week |
|
|
| t-test, 2 sided |
| 0.305 |
| Other |