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

Primary Purpose

Epilepsy, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TIME
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Intervention, Treatment, Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TIME

Treatment as Usual (TAU)

Arm Description

This arm will receive the TIME intervention.

This arm will receive treatment as usual.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Quality of Life Questionnaire (QOLIE-10)
The QOLIE-10-P is a self-administered questionnaire and comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The sum score is used in the analysis. Scores from 1-5 with lower scores indicating the least amount of problems
Patient Health Questionnaire (PHQ-9)
Scores from 0-27 with higher scores indicating more severe depressive symptoms.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI contains 19 self-rated questions that are combined to form seven "component" scores each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21, "0" indicating no difficulty and "21" indicating severe difficulties in all areas (with higher scores indicating worse sleep quality).
Brief Psychiatric Rating Scale (BPRS)
The BPRS is a tool clinicians or researchers use to measure psychiatric symptoms such as anxiety, depression, and psychoses. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. The total Score is the sum of all 18-items. Score ranges from 18-126 with higher scores indicating more psychiatric symptoms.
Global Assessment of Functioning (GAF)
The GAF assesses psychological, social and occupational functioning on a hypothetical continuum of mental health illness. Scores range from 0-100 with higher scores indicating higher global functioning.
Seizure Frequency - Past 30 Days
Self reported seizure frequency in the past 30 days

Full Information

First Posted
November 14, 2013
Last Updated
September 12, 2022
Sponsor
Case Western Reserve University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01992393
Brief Title
Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)
Official Title
Targeted Self-Management for Epilepsy and Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression
Keywords
Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Intervention, Treatment, Adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIME
Arm Type
Experimental
Arm Description
This arm will receive the TIME intervention.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
This arm will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
TIME
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Description
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 Outcome Measure Information:
Title
World Health Organization Disability Assessment (WHODAS II)
Description
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.
Time Frame
Baseline, 12 Week, 16 Week
Title
Quality of Life Questionnaire (QOLIE-10)
Description
The QOLIE-10-P is a self-administered questionnaire and comprises 7 components including seizure worry, overall quality of life, emotional well-being, energy-fatigue, cognitive functioning, medication effect, and social function. The sum score is used in the analysis. Scores from 1-5 with lower scores indicating the least amount of problems
Time Frame
Baseline, 12 Week, 16 Week
Title
Patient Health Questionnaire (PHQ-9)
Description
Scores from 0-27 with higher scores indicating more severe depressive symptoms.
Time Frame
Baseline, 12 Week, 16 Week
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI contains 19 self-rated questions that are combined to form seven "component" scores each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21, "0" indicating no difficulty and "21" indicating severe difficulties in all areas (with higher scores indicating worse sleep quality).
Time Frame
Baseline, 12 Week, 16 Week
Title
Brief Psychiatric Rating Scale (BPRS)
Description
The BPRS is a tool clinicians or researchers use to measure psychiatric symptoms such as anxiety, depression, and psychoses. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses. The total Score is the sum of all 18-items. Score ranges from 18-126 with higher scores indicating more psychiatric symptoms.
Time Frame
Baseline, 12 Week, 16 Week
Title
Global Assessment of Functioning (GAF)
Description
The GAF assesses psychological, social and occupational functioning on a hypothetical continuum of mental health illness. Scores range from 0-100 with higher scores indicating higher global functioning.
Time Frame
Baseline, 12 Week, 16 Week
Title
Seizure Frequency - Past 30 Days
Description
Self reported seizure frequency in the past 30 days
Time Frame
Baseline, 12 Week, 16 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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