Bipolar Disorder, Depression, Epilepsy, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Intervention, Treatment, Adherence
Brief summary
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.
Interventions
BEHAVIORALTIME
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.
Sponsors
Centers for Disease Control and Prevention
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide written consent * Able to speak and understand English * Age 18 and older * Diagnosed with epilepsy * Diagnosed with serious mental illness (DSM IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or chronic/recurrent depression confirmed with the Mini-International Neuropsychiatric Interview (MINI)) * Receive care at a community mental health center or other publicly funded community healthcare entity
Exclusion criteria
* Actively suicidal/homicidal individuals * Individuals with dementia * Unable to be rated on study rating scales * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery Asberg Depression Rating Scale (MADRS) | Baseline to Week 16 | The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire (QOLIE-10) | Baseline, 12 Week, 16 Week | 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 |
| Patient Health Questionnaire (PHQ-9) | Baseline, 12 Week, 16 Week | Scores from 0-27 with higher scores indicating more severe depressive symptoms. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, 12 Week, 16 Week | 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). |
| World Health Organization Disability Assessment (WHODAS II) | Baseline, 12 Week, 16 Week | 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. |
| Global Assessment of Functioning (GAF) | Baseline, 12 Week, 16 Week | 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. |
| Seizure Frequency - Past 30 Days | Baseline, 12 Week, 16 Week | Self reported seizure frequency in the past 30 days |
| Brief Psychiatric Rating Scale (BPRS) | Baseline, 12 Week, 16 Week | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Treatment as Usual (TAU) This arm will receive treatment as usual. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | TIME | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Age, Continuous | 52.00 years STANDARD_DEVIATION 7.58 | 45.10 years STANDARD_DEVIATION 14.18 | 48.25 years STANDARD_DEVIATION 11.82 |
| Charlson Comorbidity Index (CCI) | 3.14 scores on a scale STANDARD_DEVIATION 2.47 | 1.86 scores on a scale STANDARD_DEVIATION 2.29 | 2.45 scores on a scale STANDARD_DEVIATION 2.44 |
| Duration of Epilepsy (in years) | 27.55 years STANDARD_DEVIATION 16.48 | 25.43 years STANDARD_DEVIATION 15.47 | 26.27 years STANDARD_DEVIATION 15.74 |
| Duration of Mental Health Disorder (in years) | 30.27 years STANDARD_DEVIATION 17.35 | 22.85 years STANDARD_DEVIATION 12.33 | 26.14 years STANDARD_DEVIATION 15.76 |
| Education Level High school graduate, GED, or higher | 15 Participants | 18 Participants | 33 Participants |
| Education Level Less than a high school education | 7 Participants | 4 Participants | 11 Participants |
| Employment Status Data Missing | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Other | 6 Participants | 7 Participants | 13 Participants |
| Employment Status Unable to work | 9 Participants | 10 Participants | 19 Participants |
| Employment Status Unemployed | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 21 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Income Level $25,000-$50,000 | 1 Participants | 1 Participants | 2 Participants |
| Income Level Less than $25,000 | 21 Participants | 21 Participants | 42 Participants |
| Income Level More than $50,000 | 0 Participants | 0 Participants | 0 Participants |
| Living Situation Homeless | 1 Participants | 2 Participants | 3 Participants |
| Living Situation Lives alone | 14 Participants | 8 Participants | 22 Participants |
| Living Situation Lives with other adults | 5 Participants | 11 Participants | 16 Participants |
| Living Situation Only adult in household | 2 Participants | 1 Participants | 3 Participants |
| Marital Status Married | 4 Participants | 0 Participants | 4 Participants |
| Marital Status Other | 18 Participants | 22 Participants | 40 Participants |
| Mental Health Diagnosis Bipolar Disorder | 7 Participants | 9 Participants | 16 Participants |
| Mental Health Diagnosis Depression | 7 Participants | 6 Participants | 13 Participants |
| Mental Health Diagnosis Schizophrenia | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Black/ African American | 13 Participants | 12 Participants | 25 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White/Caucasian | 8 Participants | 8 Participants | 16 Participants |
| Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) | 5.18 scores on a scale STANDARD_DEVIATION 2.77 | 6.29 scores on a scale STANDARD_DEVIATION 2.57 | 5.77 scores on a scale STANDARD_DEVIATION 2.69 |
| Seizure Type Don't know/Not sure | 1 seizures | 4 seizures | 5 seizures |
| Seizure Type Generalized | 16 seizures | 14 seizures | 30 seizures |
| Seizure Type Other | 1 seizures | 3 seizures | 4 seizures |
| Seizure Type Partial | 5 seizures | 6 seizures | 11 seizures |
| Seizure Type Unclassified | 1 seizures | 2 seizures | 3 seizures |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 2 / 22 | 0 / 22 |
| serious Total, serious adverse events | 12 / 22 | 1 / 22 |
Outcome results
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.
Time frame: Baseline to Week 16
Population: Individuals with epilepsy and comorbid mental illness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | Change in Montgomery Asberg Depression Rating Scale (MADRS) | Baseline | 16.75 score on a scale | Standard Deviation 10.28 |
| TIME | Change in Montgomery Asberg Depression Rating Scale (MADRS) | Week 16 | 11.21 score on a scale | Standard Deviation 9.36 |
| Treatment as Usual (TAU) | Change in Montgomery Asberg Depression Rating Scale (MADRS) | Baseline | 22.94 score on a scale | Standard Deviation 11.81 |
| Treatment as Usual (TAU) | Change in Montgomery Asberg Depression Rating Scale (MADRS) | Week 16 | 21.81 score on a scale | Standard Deviation 10.5 |
p-value: 0.036GEE
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.
Time frame: Baseline, 12 Week, 16 Week
Population: Individuals with epilepsy and comorbid mental illness with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | Brief Psychiatric Rating Scale (BPRS) | Baseline | 36.90 score on a scale | Standard Deviation 11.78 |
| TIME | Brief Psychiatric Rating Scale (BPRS) | 12 Week | 33.89 score on a scale | Standard Deviation 9.67 |
| TIME | Brief Psychiatric Rating Scale (BPRS) | 16 Week | 29.59 score on a scale | Standard Deviation 11.36 |
| Treatment as Usual (TAU) | Brief Psychiatric Rating Scale (BPRS) | Baseline | 37.85 score on a scale | Standard Deviation 10.39 |
| Treatment as Usual (TAU) | Brief Psychiatric Rating Scale (BPRS) | 12 Week | 35.81 score on a scale | Standard Deviation 11.24 |
| Treatment as Usual (TAU) | Brief Psychiatric Rating Scale (BPRS) | 16 Week | 35.73 score on a scale | Standard Deviation 9.63 |
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.775t-test, 2 sided
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.p-value: 0.433t-test, 2 sided
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.
Time frame: Baseline, 12 Week, 16 Week
Population: Individuals with epilepsy and comorbid mental illness with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | Global Assessment of Functioning (GAF) | Baseline | 59.23 score on a scale | Standard Deviation 17.06 |
| TIME | Global Assessment of Functioning (GAF) | 12 Week | 62.83 score on a scale | Standard Deviation 15.98 |
| TIME | Global Assessment of Functioning (GAF) | 16 Week | 69.50 score on a scale | Standard Deviation 18.27 |
| Treatment as Usual (TAU) | Global Assessment of Functioning (GAF) | Baseline | 54.57 score on a scale | Standard Deviation 13.66 |
| Treatment as Usual (TAU) | Global Assessment of Functioning (GAF) | 12 Week | 59.00 score on a scale | Standard Deviation 16.78 |
| Treatment as Usual (TAU) | Global Assessment of Functioning (GAF) | 16 Week | 59.94 score on a scale | Standard Deviation 18.38 |
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.936t-test, 2 sided
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.p-value: 0.6t-test, 2 sided
Secondary
Patient Health Questionnaire (PHQ-9)
Scores from 0-27 with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, 12 Week, 16 Week
Population: Individuals with epilepsy and comorbid mental illness with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | Patient Health Questionnaire (PHQ-9) | Baseline | 9.70 score on a scale | Standard Deviation 5.55 |
| TIME | Patient Health Questionnaire (PHQ-9) | 12 Week | 9.24 score on a scale | Standard Deviation 4.97 |
| TIME | Patient Health Questionnaire (PHQ-9) | 16 Week | 6.38 score on a scale | Standard Deviation 4.44 |
| Treatment as Usual (TAU) | Patient Health Questionnaire (PHQ-9) | Baseline | 11.76 score on a scale | Standard Deviation 5.72 |
| Treatment as Usual (TAU) | Patient Health Questionnaire (PHQ-9) | 12 Week | 13.19 score on a scale | Standard Deviation 5.67 |
| Treatment as Usual (TAU) | Patient Health Questionnaire (PHQ-9) | 16 Week | 12.87 score on a scale | Standard Deviation 6.63 |
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.128t-test, 2 sided
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.p-value: 0.015t-test, 2 sided
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).
Time frame: Baseline, 12 Week, 16 Week
Population: Individuals with epilepsy and comorbid mental illness with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 10.55 score on a scale | Standard Deviation 4.49 |
| TIME | Pittsburgh Sleep Quality Index (PSQI) | 12 Week | 8.88 score on a scale | Standard Deviation 3.3 |
| TIME | Pittsburgh Sleep Quality Index (PSQI) | 16 Week | 6.85 score on a scale | Standard Deviation 3.8 |
| Treatment as Usual (TAU) | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 12.95 score on a scale | Standard Deviation 4.38 |
| Treatment as Usual (TAU) | Pittsburgh Sleep Quality Index (PSQI) | 12 Week | 12.21 score on a scale | Standard Deviation 2.64 |
| Treatment as Usual (TAU) | Pittsburgh Sleep Quality Index (PSQI) | 16 Week | 11.45 score on a scale | Standard Deviation 3.27 |
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.759t-test, 2 sided
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.p-value: 0.471t-test, 2 sided
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
Time frame: Baseline, 12 Week, 16 Week
Population: Individuals with epilepsy and comorbid mental illness with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | Quality of Life Questionnaire (QOLIE-10) | Baseline | 2.85 units on a scale | Standard Deviation 0.82 |
| TIME | Quality of Life Questionnaire (QOLIE-10) | 12 Week | 2.38 units on a scale | Standard Deviation 0.6 |
| TIME | Quality of Life Questionnaire (QOLIE-10) | 16 Week | 2.56 units on a scale | Standard Deviation 0.89 |
| Treatment as Usual (TAU) | Quality of Life Questionnaire (QOLIE-10) | Baseline | 3.34 units on a scale | Standard Deviation 0.25 |
| Treatment as Usual (TAU) | Quality of Life Questionnaire (QOLIE-10) | 12 Week | 3.03 units on a scale | Standard Deviation 0.79 |
| Treatment as Usual (TAU) | Quality of Life Questionnaire (QOLIE-10) | 16 Week | 2.84 units on a scale | Standard Deviation 0.73 |
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.129t-test, 2 sided
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.p-value: 0.978t-test, 2 sided
Secondary
Seizure Frequency - Past 30 Days
Self reported seizure frequency in the past 30 days
Time frame: Baseline, 12 Week, 16 Week
Population: Individuals with epilepsy and comorbid mental illness with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | Seizure Frequency - Past 30 Days | Baseline | 3.67 number of seizures | Standard Deviation 14.08 |
| TIME | Seizure Frequency - Past 30 Days | 12 Week | 1.50 number of seizures | Standard Deviation 2.68 |
| TIME | Seizure Frequency - Past 30 Days | 16 Week | 1.00 number of seizures | Standard Deviation 1.97 |
| Treatment as Usual (TAU) | Seizure Frequency - Past 30 Days | Baseline | 8.79 number of seizures | Standard Deviation 32.01 |
| Treatment as Usual (TAU) | Seizure Frequency - Past 30 Days | 12 Week | 18.40 number of seizures | Standard Deviation 42.36 |
| Treatment as Usual (TAU) | Seizure Frequency - Past 30 Days | 16 Week | 6.44 number of seizures | Standard Deviation 15.21 |
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.56t-test, 2 sided
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.305t-test, 2 sided
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.
Time frame: Baseline, 12 Week, 16 Week
Population: Individuals with epilepsy and comorbid mental illness with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIME | World Health Organization Disability Assessment (WHODAS II) | 16 week | 73.39 score on a scale | Standard Deviation 24.94 |
| TIME | World Health Organization Disability Assessment (WHODAS II) | Baseline | 80.86 score on a scale | Standard Deviation 18.76 |
| TIME | World Health Organization Disability Assessment (WHODAS II) | 12 week | 67.68 score on a scale | Standard Deviation 13.29 |
| Treatment as Usual (TAU) | World Health Organization Disability Assessment (WHODAS II) | 16 week | 81.50 score on a scale | Standard Deviation 21.34 |
| Treatment as Usual (TAU) | World Health Organization Disability Assessment (WHODAS II) | Baseline | 82.83 score on a scale | Standard Deviation 23.39 |
| Treatment as Usual (TAU) | World Health Organization Disability Assessment (WHODAS II) | 12 week | 79.87 score on a scale | Standard Deviation 24.44 |
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.p-value: 0.042t-test, 2 sided
Comparison: A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAUp-value: 0.204t-test, 2 sided