N/A
N=44
Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME)
Epilepsy · Schizophrenia · Schizoaffective Disorder · Bipolar Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT01992393 ↗Enrolled (actual)
44
Serious AEs
29.5%
Results posted
Sep 2022
Primary outcome: Primary: Change in Montgomery Asberg Depression Rating Scale (MADRS) — 16.75; 22.94; 11.21; 21.81 score on a scale — p=0.036
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TIME (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery Asberg Depression Rating Scale (MADRS) |
16.75; 22.94; 11.21; 21.81 | 0.036 sig |
| SECONDARY World Health Organization Disability Assessment (WHODAS II) |
80.86; 82.83; 67.68; 79.87; 73.39; 81.50 | 0.042 sig |
| SECONDARY Quality of Life Questionnaire (QOLIE-10) |
2.85; 3.34; 2.38; 3.03; 2.56; 2.84 | 0.129 |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
9.70; 11.76; 9.24; 13.19; 6.38; 12.87 | 0.128 |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
10.55; 12.95; 8.88; 12.21; 6.85; 11.45 | 0.759 |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) |
36.90; 37.85; 33.89; 35.81; 29.59; 35.73 | 0.775 |
| SECONDARY Global Assessment of Functioning (GAF) |
59.23; 54.57; 62.83; 59.00; 69.50; 59.94 | 0.936 |
| SECONDARY Seizure Frequency - Past 30 Days |
3.67; 8.79; 1.50; 18.40; 1.00; 6.44 | 0.560 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01992393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.