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Clinical Trials/NCT01992393
NCT01992393
Completed
N/A

Targeted Self-Management for Epilepsy and Serious Mental Illness

Case Western Reserve University1 site in 1 country58 target enrollmentSeptember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Case Western Reserve University
Enrollment
58
Locations
1
Primary Endpoint
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2015
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martha Sajatovic, MD

Professor of Psychiatry

Case Western Reserve University

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

Outcomes

Primary Outcomes

Change in Montgomery Asberg Depression Rating Scale (MADRS)

Time Frame: 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 Outcomes

  • World Health Organization Disability Assessment (WHODAS II)(Baseline, 12 Week, 16 Week)
  • Quality of Life Questionnaire (QOLIE-10)(Baseline, 12 Week, 16 Week)
  • Patient Health Questionnaire (PHQ-9)(Baseline, 12 Week, 16 Week)
  • Pittsburgh Sleep Quality Index (PSQI)(Baseline, 12 Week, 16 Week)
  • Brief Psychiatric Rating Scale (BPRS)(Baseline, 12 Week, 16 Week)
  • Global Assessment of Functioning (GAF)(Baseline, 12 Week, 16 Week)
  • Seizure Frequency - Past 30 Days(Baseline, 12 Week, 16 Week)

Study Sites (1)

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