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

September 12, 2022 updated by: Martha Sajatovic, MD, Case Western Reserve University

Targeted Self-Management for Epilepsy and Serious Mental Illness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
World Health Organization Disability Assessment (WHODAS II)
Time Frame: Baseline, 12 Week, 16 Week

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.
Baseline, 12 Week, 16 Week
Quality of Life Questionnaire (QOLIE-10)
Time Frame: Baseline, 12 Week, 16 Week
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
Baseline, 12 Week, 16 Week
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 12 Week, 16 Week
Scores from 0-27 with higher scores indicating more severe depressive symptoms.
Baseline, 12 Week, 16 Week
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 12 Week, 16 Week
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).
Baseline, 12 Week, 16 Week
Brief Psychiatric Rating Scale (BPRS)
Time Frame: Baseline, 12 Week, 16 Week
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.
Baseline, 12 Week, 16 Week
Global Assessment of Functioning (GAF)
Time Frame: Baseline, 12 Week, 16 Week
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.
Baseline, 12 Week, 16 Week
Seizure Frequency - Past 30 Days
Time Frame: Baseline, 12 Week, 16 Week
Self reported seizure frequency in the past 30 days
Baseline, 12 Week, 16 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-12-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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