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

• Sponsor: Case Western Reserve University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01992393
• Collaborator: Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression	Behavioral: TIME	N/A

Study Design

• Study Type: Interventional
• 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: Sep 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Montgomery Asberg Depression Rating Scale (MADRS) [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) [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) [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) [Screen, 4 months]

   Change from screening in Multidimensional Scale of Perceived Social Support (MSPSS) at 4 months

4. Internalized Stigma of Mental Illness (ISMI) [Screen, 4 months]

   Change from screening in Internalized Stigma of Mental Illness (ISMI) at 4 months

5. Stigma Scale of Epilepsy (SSE) [Screen, 4 months]

   Change from screening in Stigma Scale of Epilepsy (SSE) at 4 months

6. Health-Related Quality of Life [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) [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) [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) [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) [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) [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 [Baseline, 4 months]

    Change from baseline in Addiction Severity Index (ASI) Drug Alcohol Use at 4 months

13. Pittsburgh Sleep Quality Index (PSQI) [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) [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) [Baseline, 3 months, 4 months]

    Change from baseline in Global Assessment of Functioning (GAF) at 3 months and 4 months

16. Clinic Visit Adherence [Baseline, 3 months, 4 months]

    Change from baseline in Clinic Visit Adherence at 3 months and 4 months

17. Adverse Events/ER Visits [Baseline, 3 months, 4 months]

    Change from baseline in Adverse Events/ER Visits at 3 months and 4 months

18. Seizure Diary [3 months, 4 months]

    Change from 3 months in Seizure Diary at 4 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martha Sajatovic, MD, Professor of Psychiatry, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT01992393
• Other Study ID Numbers: 11-12-17
• First Posted: Nov 25, 2013
• Last Update Posted: Jan 29, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Martha Sajatovic, MD, Professor of Psychiatry, Case Western Reserve University: Epilepsy; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression; Intervention; Treatment; Adherence
• Additional relevant MeSH terms: Epilepsy; Disease; Depression; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders

Study Results

No Results Posted as of Jan 29, 2016