Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)

Study Overview
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Brief Summary
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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.

Official Title
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Targeted Self-Management for Epilepsy and Serious Mental Illness

Conditions
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Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression

Intervention / Treatment
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* Behavioral: TIME


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIME<br>This arm will receive the TIME intervention. | Behavioral: TIME<br>* 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.<br>|
| No Intervention: Treatment as Usual (TAU)<br>This arm will receive treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Intervention, Treatment, Adherence