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

NCT ID: NCT01992393

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TIME

This arm will receive the TIME intervention.

Group Type: EXPERIMENTAL

TIME

Intervention Type: 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.

Treatment as Usual (TAU)

This arm will receive treatment as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Martha Sajatovic, MD

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha Sajatovic, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

11-12-17

Identifier Type: -

Identifier Source: org_study_id