EpilepsyNCT01992393

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

A study testing TIME in people with Epilepsy and Schizophrenia, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Epilepsy, Schizophrenia, Schizoaffective Disorder
What is being tested?: TIME
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Case Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Targeted Self-Management for Epilepsy and Serious Mental Illness

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
Being tested: TIME
Keywords: Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Intervention, Treatment, Adherence
Medical subject headings: Epilepsy, Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TIMEBehavioural
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.

Study groups in NCT01992393
Study group	Role	What they receive
TIME	Experimental	This arm will receive the TIME intervention. Receives: Behavioral: TIME
Treatment as Usual (TAU)	No intervention	This arm will receive treatment as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Week 16

Secondary outcomes (7)

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.
Measured: Baseline, 12 Week, 16 Week
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
Measured: Baseline, 12 Week, 16 Week
Patient Health Questionnaire (PHQ-9)
Scores from 0-27 with higher scores indicating more severe depressive symptoms.
Measured: Baseline, 12 Week, 16 Week
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).
Measured: Baseline, 12 Week, 16 Week
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.
Measured: Baseline, 12 Week, 16 Week
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.
Measured: Baseline, 12 Week, 16 Week
Seizure Frequency - Past 30 Days
Self reported seizure frequency in the past 30 days
Measured: Baseline, 12 Week, 16 Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Sep 2015

First posted25 Nov 2013 (estimated)
Study startSep 2013
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01992393
Sponsor's protocol ID: 11-12-17
Status last verified: Sep 2022
First submitted: 14 Nov 2013
Last updated: 28 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Targeted Self-Management for Epilepsy and Serious Mental Illness
ClinicalTrials.gov ID: NCT01992393
Acronym / sponsor ID: 11-12-17
Conditions: Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression
Keywords: Epilepsy, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Intervention, Treatment, Adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention
Study start: Sep 2013
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 28 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TIME	Experimental	Behavioral: TIMEThis arm will receive the TIME intervention.
Treatment as Usual (TAU)	No intervention	–This arm will receive treatment as usual.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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))

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TIMETIME 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.	Behavioural	TIME

Primary outcome

Change in Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline to Week 16
The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression.

7 secondary outcomes

World Health Organization Disability Assessment (WHODAS II)
Time frame: Baseline, 12 Week, 16 Week
Quality of Life Questionnaire (QOLIE-10)
Time frame: Baseline, 12 Week, 16 Week
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 12 Week, 16 Week
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 12 Week, 16 Week
Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline, 12 Week, 16 Week
Global Assessment of Functioning (GAF)
Time frame: Baseline, 12 Week, 16 Week
Seizure Frequency - Past 30 Days
Time frame: Baseline, 12 Week, 16 Week

Results and safety

Results posted to the registry on 28 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TIME	22	21
Treatment as Usual (TAU)	22	22

Primary outcome: Change in Montgomery Asberg Depression Rating Scale (MADRS)

Time frame: Baseline to Week 16. Mean (Standard Deviation). Unit: score on a scale

Measure	TIME n = 22	Treatment as Usual (TAU) n = 22
Baseline	16.75 (10.28)	22.94 (11.81)
Week 16	11.21 (9.36)	21.81 (10.50)

TIME vs Treatment as Usual (TAU): p = 0.036, GEE

Population analysed: Individuals with epilepsy and comorbid mental illness.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events will be reviewed by study Principal Investigators on an ongoing basis during the study period of 4 months.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIME	12 of 22 (54.5%)	2 of 22 (9.1%)	0 of 22
Treatment as Usual (TAU)	1 of 22 (4.5%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martha Sajatovic, MD principal investigator

Case Western Reserve University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TIME in people with Epilepsy and Schizophrenia, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery Asberg Depression Rating Scale (MADRS) (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01992393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.