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

Case Western Reserve University logo

Case Western Reserve University

Status

Completed

Conditions

Epilepsy
Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Depression

Treatments

Behavioral: TIME

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01992393
11-12-17

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

TIME
Experimental group
Description:
This arm will receive the TIME intervention.
Treatment:
Behavioral: TIME
Treatment as Usual (TAU)
No Intervention group
Description:
This arm will receive treatment as usual.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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