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

NCT01992393 | Completed Results

• 1 other identifier: 11-12-17
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression

Keywords

Epilepsy; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression; Intervention; Treatment; Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 16

Secondary Outcomes (7)

• World Health Organization Disability Assessment (WHODAS II)

  Baseline, 12 Week, 16 Week

• Quality of Life Questionnaire (QOLIE-10)

  Baseline, 12 Week, 16 Week

• Patient Health Questionnaire (PHQ-9)

  Baseline, 12 Week, 16 Week

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 12 Week, 16 Week

• Brief Psychiatric Rating Scale (BPRS)

  Baseline, 12 Week, 16 Week

Study Arms (2)

TIME

EXPERIMENTAL

This arm will receive the TIME intervention.

Behavioral: TIME

Treatment as Usual (TAU)

NO INTERVENTION

This arm will receive treatment as usual.

Interventions

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.

TIME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Actively suicidal/homicidal individuals
• Individuals with dementia
• Unable to be rated on study rating scales
• Pregnant women

Sponsors & Collaborators

• Case Western Reserve University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Epilepsy; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Depression

Interventions

Time

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physical Phenomena

Limitations and Caveats

Limitations included small sample size \& a single-site setting which may not be representative of people with E-MI. Those who agree to participate in a clinical trial may be more help-seeking than individuals with E-MI more broadly. We excluded individuals too psychiatrically ill to participate in groups. Additionally, raters were not blind to randomization assignment, we did not collect information on psychotropic medication changes or adherence, \& epilepsy diagnosis was not verified with EEG.

Results Point of Contact

• Title: Joy Yala, Data & Regulatory Coordinator II
• Organization: Case Western Reserve University

jxy790@case.edu

216-368-0783

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 25, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Locations

US (1)