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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Case Western Reserve University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01992393
First received: November 14, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Epilepsy
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Behavioral: TIME

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Targeted Self-Management for Epilepsy and Serious Mental Illness

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Screen, Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from screening in Montgomery Asberg Depression Rating Scale (MADRS) at baseline, 3 months, and 4 months


Secondary Outcome Measures:
  • Epilepsy Self-Efficacy Scale (ESES) [ Time Frame: Screen, 4 months ] [ Designated as safety issue: No ]
    Change from screening in Epilepsy Self-Efficacy Scale (ESES) at 4 months

  • Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) [ Time Frame: Screen, 4 months ] [ Designated as safety issue: No ]
    Change from screening in Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) at 4 months

  • Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Screen, 4 months ] [ Designated as safety issue: No ]
    Change from screening in Multidimensional Scale of Perceived Social Support (MSPSS) at 4 months

  • Internalized Stigma of Mental Illness (ISMI) [ Time Frame: Screen, 4 months ] [ Designated as safety issue: No ]
    Change from screening in Internalized Stigma of Mental Illness (ISMI) at 4 months

  • Stigma Scale of Epilepsy (SSE) [ Time Frame: Screen, 4 months ] [ Designated as safety issue: No ]
    Change from screening in Stigma Scale of Epilepsy (SSE) at 4 months

  • Health-Related Quality of Life [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Health-Related Quality of Life at 3 months and 4 months

  • Tablet Routines Questionnaire (TRQ) [ Time Frame: Screen, Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from screening in Tablet Routines Questionnaire (TRQ) at baseline, 3 months, and 4 months

  • World Health Organization Disability Assessment (WHODAS II) [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in World Health Organization Disability Assessment (WHODAS II) at 3 months and 4 months

  • Quality of Life Questionnaire (QOLIE-10) [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Quality of Life Questionnaire (QOLIE-10) at 3 months and 4 months

  • Neurology Quality of Life measures (Neuro-QOL) [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Neurology Quality of Life measures (Neuro-QOL) at 3 months and 4 months

  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Patient Health Questionnaire (PHQ-9) at 3 months and 4 months

  • Addiction Severity Index (ASI) Drug Alcohol Use [ Time Frame: Baseline, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Addiction Severity Index (ASI) Drug Alcohol Use at 4 months

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 3 months and 4 months

  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Brief Psychiatric Rating Scale (BPRS) at 3 months and 4 months

  • Global Assessment of Functioning (GAF) [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Global Assessment of Functioning (GAF) at 3 months and 4 months

  • Clinic Visit Adherence [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: No ]
    Change from baseline in Clinic Visit Adherence at 3 months and 4 months

  • Adverse Events/ER Visits [ Time Frame: Baseline, 3 months, 4 months ] [ Designated as safety issue: Yes ]
    Change from baseline in Adverse Events/ER Visits at 3 months and 4 months

  • Seizure Diary [ Time Frame: 3 months, 4 months ] [ Designated as safety issue: Yes ]
    Change from 3 months in Seizure Diary at 4 months


Estimated Enrollment: 44
Study Start Date: September 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TIME
This arm will receive the TIME intervention.
Behavioral: TIME
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.
No Intervention: Treatment as Usual (TAU)
This arm will receive treatment as usual.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992393

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Martha Sajatovic, MD    216-844-2808    Martha.Sajatovic@UHhospitals.org   
Principal Investigator: Martha Sajatovic, MD         
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Martha Sajatovic, MD, Professor of Psychiatry, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01992393     History of Changes
Other Study ID Numbers: 11-12-17
Study First Received: November 14, 2013
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Epilepsy
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Intervention
Treatment
Adherence

Additional relevant MeSH terms:
Mental Disorders
Depression
Depressive Disorder
Schizophrenia
Disease
Epilepsy
Bipolar Disorder
Psychotic Disorders
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Affective Disorders, Psychotic

ClinicalTrials.gov processed this record on September 18, 2014