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

Depression Clinical Trial

Official title:

Targeted Self-Management for Epilepsy and Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992393
• Other study ID #: 11-12-17
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Disease
• Epilepsy
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

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.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	World Health Organization Disability Assessment (WHODAS II)	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.	Baseline, 12 Week, 16 Week
Secondary	Quality of Life Questionnaire (QOLIE-10)	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	Baseline, 12 Week, 16 Week
Secondary	Patient Health Questionnaire (PHQ-9)	Scores from 0-27 with higher scores indicating more severe depressive symptoms.	Baseline, 12 Week, 16 Week
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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).	Baseline, 12 Week, 16 Week
Secondary	Brief Psychiatric Rating Scale (BPRS)	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.	Baseline, 12 Week, 16 Week
Secondary	Global Assessment of Functioning (GAF)	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.	Baseline, 12 Week, 16 Week
Secondary	Seizure Frequency - Past 30 Days	Self reported seizure frequency in the past 30 days	Baseline, 12 Week, 16 Week