Clinical trial NCT01992393: Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)
Official title: Targeted Self-Management for Epilepsy and Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Keywords: Epilepsy
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Intervention
Treatment
Adherence
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-11-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: World Health Organization Disability Assessment (WHODAS II)
timeFrame: Baseline, 12 Week, 16 Week
measure: Quality of Life Questionnaire (QOLIE-10)
timeFrame: Baseline, 12 Week, 16 Week
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 12 Week, 16 Week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 12 Week, 16 Week
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline, 12 Week, 16 Week
measure: Global Assessment of Functioning (GAF)
timeFrame: Baseline, 12 Week, 16 Week
measure: Seizure Frequency - Past 30 Days
timeFrame: Baseline, 12 Week, 16 Week
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References: