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Completed

NCT Number: NCT01992393

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

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.

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Key information

Conditions

Epilepsy Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Brain Diseases Central Nervous System Diseases Depression Mental Disorders Mood Disorders Nervous System Diseases Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIME

Behavioral

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 outcomes

  1. 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

  1. 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.

  2. 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

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, 12 Week, 16 Week

    Scores from 0-27 with higher scores indicating more severe depressive symptoms.

  4. 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).

  5. 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.

  6. 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.

  7. Seizure Frequency - Past 30 Days

    Time frame: Baseline, 12 Week, 16 Week

    Self reported seizure frequency in the past 30 days

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Targeted Self-Management for Epilepsy and Serious Mental Illness

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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