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

N/ACompletedNCT01992393

Case Western Reserve University58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Epilepsy Schizophrenia Schizoaffective Disorder

Interventions

TIMEBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.