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

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ClinicalTrials.gov Identifier: NCT01992393
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : January 29, 2016
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Martha Sajatovic, MD, 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.


Condition or disease Intervention/treatment Phase
Epilepsy Schizophrenia Schizoaffective Disorder Bipolar Disorder Depression Behavioral: TIME Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Targeted Self-Management for Epilepsy and Serious Mental Illness
Study Start Date : September 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Screen, Baseline, 3 months, 4 months ]
    Change from screening in Montgomery Asberg Depression Rating Scale (MADRS) at baseline, 3 months, and 4 months


Secondary Outcome Measures :
  1. Epilepsy Self-Efficacy Scale (ESES) [ Time Frame: Screen, 4 months ]
    Change from screening in Epilepsy Self-Efficacy Scale (ESES) at 4 months

  2. Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) [ Time Frame: Screen, 4 months ]
    Change from screening in Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) at 4 months

  3. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Screen, 4 months ]
    Change from screening in Multidimensional Scale of Perceived Social Support (MSPSS) at 4 months

  4. Internalized Stigma of Mental Illness (ISMI) [ Time Frame: Screen, 4 months ]
    Change from screening in Internalized Stigma of Mental Illness (ISMI) at 4 months

  5. Stigma Scale of Epilepsy (SSE) [ Time Frame: Screen, 4 months ]
    Change from screening in Stigma Scale of Epilepsy (SSE) at 4 months

  6. Health-Related Quality of Life [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Health-Related Quality of Life at 3 months and 4 months

  7. Tablet Routines Questionnaire (TRQ) [ Time Frame: Screen, Baseline, 3 months, 4 months ]
    Change from screening in Tablet Routines Questionnaire (TRQ) at baseline, 3 months, and 4 months

  8. World Health Organization Disability Assessment (WHODAS II) [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in World Health Organization Disability Assessment (WHODAS II) at 3 months and 4 months

  9. Quality of Life Questionnaire (QOLIE-10) [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Quality of Life Questionnaire (QOLIE-10) at 3 months and 4 months

  10. Neurology Quality of Life measures (Neuro-QOL) [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Neurology Quality of Life measures (Neuro-QOL) at 3 months and 4 months

  11. Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Patient Health Questionnaire (PHQ-9) at 3 months and 4 months

  12. Addiction Severity Index (ASI) Drug Alcohol Use [ Time Frame: Baseline, 4 months ]
    Change from baseline in Addiction Severity Index (ASI) Drug Alcohol Use at 4 months

  13. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 3 months and 4 months

  14. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Brief Psychiatric Rating Scale (BPRS) at 3 months and 4 months

  15. Global Assessment of Functioning (GAF) [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Global Assessment of Functioning (GAF) at 3 months and 4 months

  16. Clinic Visit Adherence [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Clinic Visit Adherence at 3 months and 4 months

  17. Adverse Events/ER Visits [ Time Frame: Baseline, 3 months, 4 months ]
    Change from baseline in Adverse Events/ER Visits at 3 months and 4 months

  18. Seizure Diary [ Time Frame: 3 months, 4 months ]
    Change from 3 months in Seizure Diary at 4 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992393


Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University

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
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Disease
Depression
Schizophrenia
Epilepsy
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bipolar and Related Disorders