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

Not Applicable

Completed

Conditions: Epilepsy
Bipolar Disorder
Schizoaffective Disorder
Depression
Schizophrenia

Interventions: Behavioral: TIME

Registration Number: NCT01992393

Lead Sponsor: Case Western Reserve University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIME	TIME	This arm will receive the TIME intervention.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.
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